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510(k) K841465

GENERAL DIAGNOSTICS PLATELET ANTIBODY by General Diagnostics — Product Code LLG

K841465 is an FDA 510(k) premarket notification submitted by General Diagnostics for the device "GENERAL DIAGNOSTICS PLATELET ANTIBODY". The FDA issued a decision of Substantially Equivalent on July 2, 1984. The device falls under product code LLG (Kit, Igg, Platelet Associated), a Class II device regulated under 21 CFR 864.5425. General Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1984
Date Received
April 9, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Igg, Platelet Associated
Device Class
Class II
Regulation Number
864.5425
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)
  • 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)
  • K830731 — NETILMICIN 30 MCG ANTIMICROBIAL DISK (April 8, 1983)

Other clearances for product code LLG

  • K840257 — RAPID IMMUNO-ASSAY SYS (April 19, 1984)

FDA data resources