VERIFY S PROD. #34141— 510(k) K800925

Substantially Equivalent

General Diagnostics

FDA 510(k) clearance K800925 for VERIFY S PROD. #34141, Substantially Equivalent on 1980-07-21. Applicant: General Diagnostics. Device class: 2.

Clearance details

Applicant: General Diagnostics
Product code: Code GGW
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1980-04-21
Decision date: 1980-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGW

K260551 — HemosIL Factor V Leiden (APC Resistance V)2026-03-20
K090105 — LUPOTEK KCT2010-12-30
K083729 — HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN2009-05-08
K060284 — CRYOCHECK CLOT APCR2006-05-10
K042762 — PEFAKIT APC-R FACTOR V LEIDEN2004-12-22

More clearances from General Diagnostics

K882663 — BARBITURATE ENZYME IMMUNOASSAY KIT1988-09-19
K872882 — CANNABINOID ENZYME IMMUNOASSAY KIT1987-11-03
K871305 — COCAINE METABOLITE ENZYME IMMUNOASSAY KIT1987-06-05
K864993 — QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE1987-03-31
K863877 — BENZODIAZEPINE ENZYME IMMUNOASSAY KIT1987-03-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.