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510(k) K890148

ATS TB RAPID STAIN SET PRODUCT #034-45 by Alpha-Tec Systems, Inc. — Product Code ICL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1989
Date Received
January 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Carbol Fuchsin
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Alpha-Tec Systems, Inc.

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  • K890020 — ATS LUGOL'S IODINE SOLUTION (February 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)
  • K881879 — ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 (May 13, 1988)

Other clearances for product code ICL

  • K842933 — CARBOL-FUCHSIN, ZIEHL-NEEDSEN (September 11, 1984)
  • K792483 — STAINS, COUNTERSTAINS & GEN. PURPOSE (December 18, 1979)
  • K771390 — HISTOCHEMICAL AFB DEMONSTRATION (August 22, 1977)