Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K873678
Device Name SPECTROPHOTOMETER (MICROASSAY PLATE READERS)
Applicant
Slt Labinstruments, Inc.
Medical Marketing Consultants
3 Bethesda Metro Center Ste750
Bethesda,  MD  20817
Applicant Contact JOYCE DAVIS
Correspondent
Slt Labinstruments, Inc.
Medical Marketing Consultants
3 Bethesda Metro Center Ste750
Bethesda,  MD  20817
Correspondent Contact JOYCE DAVIS
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received09/14/1987
Decision Date 09/29/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-