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510(k) K850680

ENCORE FERRITIN REAGENT by Hybritech, Inc. — Product Code JMB

K850680 is an FDA 510(k) premarket notification submitted by Hybritech, Inc. for the device "ENCORE FERRITIN REAGENT". The FDA issued a decision of Substantially Equivalent on March 21, 1985. The device falls under product code JMB (Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase), a Class II device regulated under 21 CFR 864.7360. Hybritech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1985
Date Received
February 21, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase
Device Class
Class II
Regulation Number
864.7360
Review Panel
HE
Submission Type

Other clearances by Hybritech, Inc.

  • K972666 — TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY (September 11, 1997)
  • 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)
  • 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)

FDA data resources