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510(k) K770527

CANDIDA IMMUNODIFFUSION KIT by I M, Inc. — Product Code GMI

K770527 is an FDA 510(k) premarket notification submitted by I M, Inc. for the device "CANDIDA IMMUNODIFFUSION KIT". The FDA issued a decision of Substantially Equivalent on March 17, 1978. The device falls under product code GMI (Antigen, Cf And / Or Id, 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
March 17, 1978
Date Received
March 18, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf And / Or Id, 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 GMI

  • K894617 — OLYMPUS PK-TP SYSTEM REACTIVE CONTROL (October 31, 1989)
  • K812190 — COCCIDIOIDES IMMUNODIFFUSION SYSTEM (August 31, 1981)
  • K812185 — FUNGAL IMMUNODIFFUSION SYSTEM (August 25, 1981)
  • K802129 — IMMUNODIFFUSION REAGENTS/SEROLOGICAL (September 26, 1980)
  • K792716 — CANDIDA ALBICANS, ANTIGEN (January 24, 1980)
  • K792713 — CANDIDA ALBICANS, ANTISERUM (January 23, 1980)
  • K792682 — COCCIDIOIDES IMMITIS, ANTIGEN (January 17, 1980)
  • K792689 — COCCIDIOIDES IMMITIS, ANTIGEN (January 17, 1980)
  • K791389 — COCCIDIOIDES ANTIGEN #CF10023X (August 16, 1979)
  • K791383 — CANDIDA IMMUNODIFFUSION KIT #CA1001 (August 16, 1979)

FDA data resources