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510(k) K870769

AUSTIN NONFERMENTER KIT by Austin Biological Laboratories — Product Code JSW

K870769 is an FDA 510(k) premarket notification submitted by Austin Biological Laboratories for the device "AUSTIN NONFERMENTER KIT". The FDA issued a decision of Substantially Equivalent on April 3, 1987. The device falls under product code JSW (Kit, Identification, Glucose Nonfermenter), 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
April 3, 1987
Date Received
February 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Glucose Nonfermenter
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)
  • K864069 — PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID (November 13, 1986)
  • K862560 — PRECEPT CEFTIZOXIME (July 11, 1986)
  • K862446 — PRECEPT CEFTAZIDIME (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)
  • K853685 — PRECEPT TM CARBENICILLIN (September 16, 1985)

Other clearances for product code JSW

  • K922768 — RAPID NFT, MODIFICATION (October 14, 1992)
  • K900517 — RAPID NF SYSTEM (March 13, 1990)
  • K790992 — PSEUDO-PALETTE TM (June 22, 1979)
  • K772112 — NON-FERMENTER SYSTEM (November 17, 1977)
  • K770745 — PANEL, GNF, MICRO-ID (June 23, 1977)

FDA data resources