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510(k) K871235

TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT by Hybritech, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1987
Date Received
March 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Hybritech, Inc.

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  • 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)
  • K920556 — TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET (July 17, 1992)
  • K921252 — TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL (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)

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