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510(k) K901645

ANAEROBIC ACCU-CULSHURE(TM) by Medical Laboratory Automation Systems, Inc. — Product Code JTX

K901645 is an FDA 510(k) premarket notification submitted by Medical Laboratory Automation Systems, Inc. for the device "ANAEROBIC ACCU-CULSHURE(TM)". The FDA issued a decision of Substantially Equivalent on July 16, 1990. The device falls under product code JTX (Transport Systems, Anaerobic), a Class I device regulated under 21 CFR 866.2900. Medical Laboratory Automation Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1990
Date Received
April 9, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transport Systems, Anaerobic
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type

Other clearances by Medical Laboratory Automation Systems, Inc.

  • K962664 — ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER (September 10, 1996)
  • K944227 — ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER (February 3, 1995)
  • K931206 — ELECTRA 1600C AUTOMATIC COAGULATION TIMER (August 23, 1993)
  • K923220 — THROMBIN CLOT TIME TEST PROCEDURE (September 29, 1992)
  • K903638 — GASTRO-INTESTINAL ACCU-CULSHURE TM (January 18, 1991)
  • K903405 — CHLAMYDIA ACCU-CULSHURE TM (October 16, 1990)
  • K903406 — VIRAL ACCU-CULSHURE TM (October 16, 1990)
  • K894052 — ELECTRA 1000C AUTOMATIC COAGULATION TIMER (July 27, 1989)
  • K884863 — ELECTRA 900C AUTOMATIC COAGULATION TIMER (February 3, 1989)
  • K871687 — TYTEM(R) REAGENT DISPENSER (May 20, 1987)

Other clearances for product code JTX

  • K897151 — ACUSON V328 AND C5432 TRANSDUCERS (July 3, 1990)
  • K882637 — ACCU-CULSHURE TM (July 6, 1988)
  • K791724 — BIO-BAG ENVIRONMENTAL CHAMBER (A & B) (October 17, 1979)
  • K781376 — STANDARDIZE TGCL & TGCH (September 14, 1978)
  • K780159 — ANASWAB (February 13, 1978)
  • K761241 — PRE-DUCED SURGI-SWAB & TRANSPORTER TUBE (December 30, 1976)
  • K760063 — SPECIMEN COLLECTOR, ANAEROBIC (August 3, 1976)

FDA data resources