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510(k) K781814

SULFATE, FIBRIQUIK PROTAMINE by General Diagnostics — Product Code JBN

K781814 is an FDA 510(k) premarket notification submitted by General Diagnostics for the device "SULFATE, FIBRIQUIK PROTAMINE". The FDA issued a decision of Substantially Equivalent on November 8, 1978. The device falls under product code JBN (Fibrin Monomer Paracoagulation), a Class II device regulated under 21 CFR 864.7300. General Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1978
Date Received
October 26, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrin Monomer Paracoagulation
Device Class
Class II
Regulation Number
864.7300
Review Panel
HE
Submission Type

Other clearances by General Diagnostics

  • K882663 — BARBITURATE ENZYME IMMUNOASSAY KIT (September 19, 1988)
  • K872882 — CANNABINOID ENZYME IMMUNOASSAY KIT (November 3, 1987)
  • K871305 — COCAINE METABOLITE ENZYME IMMUNOASSAY KIT (June 5, 1987)
  • K864993 — QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE (March 31, 1987)
  • K863877 — BENZODIAZEPINE ENZYME IMMUNOASSAY KIT (March 12, 1987)
  • K842307 — GENERAL DIAG. CEFONICID 30MCG ANTIMIC (July 20, 1984)
  • K841465 — GENERAL DIAGNOSTICS PLATELET ANTIBODY (July 2, 1984)
  • K833709 — CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK (December 30, 1983)
  • K832653 — CEFUROXIME 30MCG. SUSCEP DISK (October 14, 1983)
  • K831179 — CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP (May 9, 1983)

Other clearances for product code JBN

  • K854015 — FS TEST KIT (March 6, 1986)

FDA data resources