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510(k) K782070

REAGENT, COCCI LATEX by I M, Inc. — Product Code GMG

K782070 is an FDA 510(k) premarket notification submitted by I M, Inc. for the device "REAGENT, COCCI LATEX". The FDA issued a decision of Substantially Equivalent on February 1, 1979. The device falls under product code GMG (Antigen, Latex Agglutination, Coccidioides Immitis), a Class II device regulated under 21 CFR 866.3135. I M, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1979
Date Received
December 12, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Latex Agglutination, Coccidioides Immitis
Device Class
Class II
Regulation Number
866.3135
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 GMG

  • K812189 — COCCIDIOIDES LATEX AGGLUTINATION (August 25, 1981)
  • K792690 — COCCIDIOIDES IMMITIS, LATEX AGGLUTI (January 17, 1980)
  • K791381 — COCCIDIODES (COCCI) (August 16, 1979)
  • K760829 — COCCIDIOIDES MYCELIAL ANTIGEN (November 1, 1976)

FDA data resources