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510(k) K921252

TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL by Hybritech, Inc. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1992
Date Received
March 16, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
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)
  • 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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