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510(k) K880990

ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION by Alpha-Tec Systems, Inc. — Product Code JSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1988
Date Received
March 8, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Mycobacteria
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Alpha-Tec Systems, Inc.

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  • K890020 — ATS LUGOL'S IODINE SOLUTION (February 24, 1989)
  • K890148 — ATS TB RAPID STAIN SET PRODUCT #034-45 (January 24, 1989)
  • K890022 — ATS MAYER'S ALBUMIN (January 10, 1989)
  • K883048 — ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION (August 17, 1988)
  • K883049 — ATS PARA-SET IODINE ALCOHOL SOLUTION (August 17, 1988)
  • K883062 — ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID (August 4, 1988)
  • K881949 — ATS NAC-PAC SET (May 25, 1988)
  • K881698 — ATS PVA FIXATIVE SOLUTION (May 13, 1988)

Other clearances for product code JSY

  • K943050 — MYCOAKT M KANSASII CULTURE ID KIT (March 13, 1995)
  • K943051 — MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT (March 13, 1995)
  • K943049 — MYCOAKT M. AVIUM CULTURE ID KIT (March 13, 1995)
  • K830211 — API TB-IDENT* (March 24, 1983)