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510(k) K832051

RIM-HAEMOPHILUS 1 & 2 by Austin Biological Laboratories — Product Code JST

K832051 is an FDA 510(k) premarket notification submitted by Austin Biological Laboratories for the device "RIM-HAEMOPHILUS 1 & 2". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code JST (Kit, Fastidious Organisms), a Class I device regulated under 21 CFR 866.2660. Austin Biological Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
June 24, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Fastidious Organisms
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Austin Biological Laboratories

  • K880511 — XACT NEISSERIA (August 25, 1988)
  • K874727 — PRECEPT(TM) CIPROFLOXACIN (February 18, 1988)
  • K870769 — AUSTIN NONFERMENTER KIT (April 3, 1987)
  • K864069 — PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID (November 13, 1986)
  • K862446 — PRECEPT CEFTAZIDIME (July 11, 1986)
  • K862560 — PRECEPT CEFTIZOXIME (July 11, 1986)
  • K860194 — AUSTIN ENTERIC SYSTEM (February 20, 1986)
  • K860195 — PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE (February 20, 1986)
  • K854577 — PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) (February 5, 1986)
  • K853772 — PRECEPT METHICILLIN (September 16, 1985)

Other clearances for product code JST

  • K962423 — BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM (August 2, 1996)
  • K854732 — API 50 CHB (CULTURE MEDIA) (March 4, 1986)
  • K841661 — SYNTHETIC BROTH A.O.A.C. (May 11, 1984)
  • K832239 — RIM-HAEMOPHILUS 2 (August 12, 1983)
  • K831349 — STREPTOCOCUS ID PLATE (May 16, 1983)

FDA data resources