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510(k) K850052

ANAEROBE KIT by Austin Biological Laboratories — Product Code JSP

K850052 is an FDA 510(k) premarket notification submitted by Austin Biological Laboratories for the device "ANAEROBE KIT". The FDA issued a decision of Substantially Equivalent on March 5, 1985. The device falls under product code JSP (Kit, Anaerobic Identification), 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
March 5, 1985
Date Received
January 8, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Anaerobic Identification
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 JSP

  • K945487 — LYFO(TM) DIFFERENTIAL DISK (May 11, 1995)
  • K945488 — LYFO(TM) DIFFERENTIAL DISK (May 11, 1995)
  • K945489 — LYFO(TM) DIFFERENTIAL DISK (May 11, 1995)
  • K944528 — BBLCRYSTAL ANAEROBE ID SYSTEM (March 7, 1995)
  • K910666 — VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION (April 3, 1991)
  • K900996 — VITEK ANAEROBE IDENTIFICATION CARD (May 11, 1990)
  • K881380 — B. FRAGTEX (October 6, 1988)
  • K882960 — IDS RAPID ANA SYSTEM (August 12, 1988)
  • K855235 — DIAGNOSTIC REAGENT PET-RPLA (November 4, 1986)
  • K862332 — ANAEROBE RAPID CHROMOGENIC ID PANEL (August 27, 1986)

FDA data resources