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510(k) K831655

SPECTRUM-10 by Austin Biological Laboratories — Product Code JSZ

K831655 is an FDA 510(k) premarket notification submitted by Austin Biological Laboratories for the device "SPECTRUM-10". The FDA issued a decision of Substantially Equivalent on June 17, 1983. The device falls under product code JSZ (Kit, Identification, Pseudomonas), 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
June 17, 1983
Date Received
May 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Pseudomonas
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)

FDA data resources