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510(k) K843612

MODIFICATION OF ABL MIC-10 PRECEPT SYS by Austin Biological Laboratories — Product Code LTD

K843612 is an FDA 510(k) premarket notification submitted by Austin Biological Laboratories for the device "MODIFICATION OF ABL MIC-10 PRECEPT SYS". The FDA issued a decision of Substantially Equivalent on February 19, 1985. The device falls under product code LTD (Paraquat Assay), a Class III device. Austin Biological Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1985
Date Received
September 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Paraquat Assay
Device Class
Class III
Regulation Number
Review Panel
TX
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 LTD

  • K843732 — API UNISCEPT MIC (October 24, 1984)

FDA data resources