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510(k) K780526

CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM by I M, Inc. — Product Code GMD

K780526 is an FDA 510(k) premarket notification submitted by I M, Inc. for the device "CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM". The FDA issued a decision of Substantially Equivalent on April 28, 1978. The device falls under product code GMD (Antisera, Latex Agglutination, Cryptococcus Neoformans), a Class II device regulated under 21 CFR 866.3165. I M, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1978
Date Received
March 31, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Latex Agglutination, Cryptococcus Neoformans
Device Class
Class II
Regulation Number
866.3165
Review Panel
MI
Submission Type

Other clearances by I M, Inc.

  • K914600 — NEUROLOGICAL SPONGE (December 30, 1992)
  • K892389 — BIOPSY KIT (July 17, 1989)
  • K881363 — SYRINGE PREFILLED WITH WATER (June 23, 1988)
  • K880753 — UMBILICAL CORD CLAMP (April 27, 1988)
  • K872741 — NUTRIPUMP (October 20, 1987)
  • K871495 — BANDAGES CATALOG NUMBER: 101 TO 220 (May 8, 1987)
  • K863785 — MAKLER CATHETER (December 11, 1986)
  • K854155 — STERILE SALINE SOLUTION (December 10, 1985)
  • K853287 — HUBOUT (October 17, 1985)
  • K853288 — FEEDING UNITS & TUBES (October 4, 1985)

Other clearances for product code GMD

  • K112422 — CRAG LATERAL FLOW ASSAY (LFA) (March 28, 2012)
  • K102286 — CRAG LATERAL FLOW ASSAY (CRAG LFA) (July 20, 2011)
  • K930418 — CRYPTO-LEX SYSTEM (February 17, 1994)
  • K933997 — PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY (November 22, 1993)
  • K894845 — (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE (September 8, 1989)
  • K812188 — CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI (August 31, 1981)
  • K810510 — YA-CRYPTO ANTIBODY TUBE AGGLUTINATION (March 20, 1981)
  • K792693 — CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX (January 21, 1980)
  • K791382 — CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION (August 16, 1979)

FDA data resources