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510(k) K860194

AUSTIN ENTERIC SYSTEM by Austin Biological Laboratories — Product Code JSE

K860194 is an FDA 510(k) premarket notification submitted by Austin Biological Laboratories for the device "AUSTIN ENTERIC SYSTEM". The FDA issued a decision of Substantially Equivalent on February 20, 1986. The device falls under product code JSE (Culture Media, Multiple Biochemical Test), a Class I device regulated under 21 CFR 866.2320. Austin Biological Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1986
Date Received
January 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Multiple Biochemical Test
Device Class
Class I
Regulation Number
866.2320
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)
  • K860195 — PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE (February 20, 1986)
  • K854577 — PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) (February 5, 1986)
  • K853685 — PRECEPT TM CARBENICILLIN (September 16, 1985)
  • K853772 — PRECEPT METHICILLIN (September 16, 1985)

Other clearances for product code JSE

  • K962265 — MLX MICROTITER PLATE LUMINOMETER (July 25, 1996)
  • K883996 — X-ACT LDC/IND (October 12, 1988)
  • K883995 — X-ACT UREA/TDA (October 12, 1988)
  • K880133 — MIL MEDIUM (March 31, 1988)
  • K880116 — MRVP BROTH (March 31, 1988)
  • K874537 — KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR (November 20, 1987)
  • K871096 — CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES (April 3, 1987)
  • K864674 — MICRODILUTION IDENTIFICATION PANELS (January 5, 1987)
  • K862393 — BIOTIS LITMUS MILK (July 3, 1986)
  • K860415 — BIOTIS SIMMON CITRATE AGAR (February 24, 1986)

FDA data resources