SIMPLATE— 510(k) K761250

Substantially Equivalent

General Diagnostics

FDA 510(k) clearance K761250 for SIMPLATE, Substantially Equivalent on 1977-03-01. Applicant: General Diagnostics. Device class: 2.

Clearance details

Applicant: General Diagnostics
Product code: Code JCA
Device class: Class 2
Regulation: 21 CFR 864.6100
Advisory panel: Hematology
Date received: 1976-12-13
Decision date: 1977-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JCA

K911745 — SIMPLATE PEDIATRIC1991-08-09
K911996 — SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION1991-07-17
K871318 — Q.I.C. BLEEDING TIME DEVICE1987-06-10
K850542 — SURGICUTT - BLEEDING TIME DEVICE1985-03-01
K830645 — BLEEDING TIME DEVICE DISPOSABLE1983-03-17

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.