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510(k) K841465

GENERAL DIAGNOSTICS PLATELET ANTIBODY by General Diagnostics — Product Code LLG

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

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  • 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)