Gibco Mycotect 189-5670

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K851275 ↗

FDA Product Code

KIW

Device Class

Class I

Regulation

21 CFR Part 864.2360

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Biphasic Blood Culture Bottle

  Class I

  FDA 510(k) K842036 Active Cleared 1 Jun 1984

• Pediatric Blood Culture Bottles

  Class I

  FDA 510(k) K810553 Active Cleared 20 Mar 1981

• Martin-Lewis Agar Medium

  Class II

  FDA 510(k) K770287 Active Cleared 18 Feb 1977

• Lombard Dowell Agar Base

  Class I

  FDA 510(k) K864014 Active Cleared 29 Oct 1986

• Gibco Mycotect Kit (Catalog No. 189-5672)

  Class I

  FDA 510(k) K860695 Active Cleared 12 Mar 1986

• Haemophilus Isolation Agar 2827

  Class I

  FDA 510(k) K841673 Active Cleared 21 May 1984

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