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510(k) K802129

IMMUNODIFFUSION REAGENTS/SEROLOGICAL by Nolan Biological Laboratories, Inc. — Product Code GMI

K802129 is an FDA 510(k) premarket notification submitted by Nolan Biological Laboratories, Inc. for the device "IMMUNODIFFUSION REAGENTS/SEROLOGICAL". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code GMI (Antigen, Cf And / Or Id, Coccidioides Immitis), a Class II device regulated under 21 CFR 866.3135. Nolan Biological Laboratories, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1980
Date Received
August 4, 1980
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 Nolan Biological Laboratories, Inc.

  • K812741 — REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS (October 23, 1981)
  • K812740 — REAGENTS FOR SERODIAGNOSIS OF ASPERGILL (October 20, 1981)
  • K802128 — IMMUNODIFFUSSION REAGENTS/SEROLOGICAL (September 26, 1980)
  • K802130 — IMMUNO. IDENTIFICATION OF H. CAPSULATUM (September 26, 1980)

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)
  • K792716 — CANDIDA ALBICANS, ANTIGEN (January 24, 1980)
  • K792713 — CANDIDA ALBICANS, ANTISERUM (January 23, 1980)
  • K792689 — COCCIDIOIDES IMMITIS, ANTIGEN (January 17, 1980)
  • K792682 — COCCIDIOIDES IMMITIS, ANTIGEN (January 17, 1980)
  • K791383 — CANDIDA IMMUNODIFFUSION KIT #CA1001 (August 16, 1979)
  • K791389 — COCCIDIOIDES ANTIGEN #CF10023X (August 16, 1979)
  • K770527 — CANDIDA IMMUNODIFFUSION KIT (March 17, 1978)

FDA data resources