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510(k) K972666

TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY by Hybritech, Inc. — Product Code CIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1997
Date Received
July 16, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class
Class II
Regulation Number
862.1050
Review Panel
CH
Submission Type

Other clearances by Hybritech, Inc.

  • K961573 — TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (August 19, 1996)
  • K930810 — TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (January 11, 1994)
  • K922754 — TANDEM-E IGE II CALIBRATION VERIFICATION SET (February 17, 1993)
  • K921745 — HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO (July 30, 1992)
  • K921252 — TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL (July 17, 1992)
  • K920556 — TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET (July 17, 1992)
  • K921763 — TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY (June 9, 1992)
  • K912439 — TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET (August 28, 1991)
  • K911417 — ICON STREP B IMMUNOENZYMETRIC ASSAY (July 24, 1991)
  • K902991 — ICON STREP B IMMUNOENZYMETRIC ASSAY (October 3, 1990)

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  • K981373 — ALKPHASE-B ASSAY KIT (May 27, 1998)
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