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 K872324
Device Name LB 9502 - CLINILUMAT, LB 952 - AUTO-CLINILUMAT
Applicant
Berthold Analytical Instruments, Inc.
28 Charron Ave.
Nashua,  NH  03063
Applicant Contact MAX E TYRRELL
Correspondent
Berthold Analytical Instruments, Inc.
28 Charron Ave.
Nashua,  NH  03063
Correspondent Contact MAX E TYRRELL
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received06/17/1987
Decision Date 08/19/1987
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
-
-