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 olive oil emulsion (turbidimetric), lipase
510(k) Number K915706
Device Name LIPASE REAGENT SET
Applicant
TECH INTL. CO.
1856 STARR-BATT DR.
ROCHESTER HILLS,  MI  48309
Applicant Contact CHEN
Correspondent
TECH INTL. CO.
1856 STARR-BATT DR.
ROCHESTER HILLS,  MI  48309
Correspondent Contact CHEN
Regulation Number862.1465
Classification Product Code
CET  
Date Received11/29/1991
Decision Date 02/18/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-