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510(k) K881502

BREWER GEL FOR CAMPYLOBACTER by Fairleigh Dickinson Laboratories, Inc. — Product Code KZJ

K881502 is an FDA 510(k) premarket notification submitted by Fairleigh Dickinson Laboratories, Inc. for the device "BREWER GEL FOR CAMPYLOBACTER". The FDA issued a decision of Substantially Equivalent on April 27, 1988. The device falls under product code KZJ (Device, Gas Generating), a Class I device regulated under 21 CFR 866.2580. Fairleigh Dickinson Laboratories, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1988
Date Received
April 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Gas Generating
Device Class
Class I
Regulation Number
866.2580
Review Panel
MI
Submission Type

Other clearances by Fairleigh Dickinson Laboratories, Inc.

  • K896032 — MODIFIED ELISA FOR CHLAMYDIA (January 29, 1990)
  • K895187 — FDL, INC.'S TRANSPORT SYSTEM (October 24, 1989)
  • K883266 — FDL ELISA FOR CHLAMYDIA (October 25, 1988)
  • K875362 — BREWER GEL FOR ANAEROBES (January 27, 1988)
  • K853307 — DIRECT ELISA FOR HERPES SIMPLEX VIRUS (December 23, 1985)
  • K850251 — ROTALOK SURGICAL HAND TABLE (February 28, 1985)

Other clearances for product code KZJ

  • K875362 — BREWER GEL FOR ANAEROBES (January 27, 1988)
  • K872782 — BBL(R) GASPAK CO2 POUCH(TM) (August 6, 1987)
  • K871709 — ANAEROBIC TRANSPORT POUCH (CATALYST-FREE) (May 15, 1987)
  • K871238 — ANABAG (April 3, 1987)
  • K862123 — BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE (June 16, 1986)
  • K853534 — BBL CAMPY POUCH (August 29, 1985)
  • K845008 — BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE (March 5, 1985)
  • K844571 — CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE (January 30, 1985)
  • K841117 — GASPAK PLUS DISPOS. HYDROGEN & (April 4, 1984)
  • K832229 — BBL ANAGEL POWDER (August 12, 1983)

FDA data resources