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510(k) K890022

ATS MAYER'S ALBUMIN by Alpha-Tec Systems, Inc. — Product Code KEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1989
Date Received
January 4, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Albumin-Based
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Alpha-Tec Systems, Inc.

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  • K890148 — ATS TB RAPID STAIN SET PRODUCT #034-45 (January 24, 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)
  • K881879 — ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 (May 13, 1988)
  • K880989 — ATS CRYPTOSPORIDIUM STAIN SET (May 13, 1988)

Other clearances for product code KEL

  • K881477 — HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED (April 18, 1988)