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FDA 510(k)

TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL

K-Number: K921252 · 1992-07-17

ApplicantHybritech, Inc.
Decision Date1992-07-17
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL is the device name listed in this FDA 510(k) record. The listed applicant is Hybritech, Inc.. It received FDA 510(k) clearance on 1992-07-17 under 510(k) number K921252. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL?

TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL is a medical device that received FDA 510(k) clearance on 1992-07-17. The listed applicant is Hybritech, Inc.. The 510(k) number is K921252.

When did TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL receive FDA 510(k) clearance?

TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL received FDA 510(k) clearance on 1992-07-17, under 510(k) number K921252.

Who is the listed applicant for TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL?

The FDA 510(k) record lists Hybritech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL?

The FDA product code for TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL is JJX.

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Other records listing Hybritech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K972666TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAYK961573TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK930810TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK922754TANDEM-E IGE II CALIBRATION VERIFICATION SETK921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNOK920556TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET

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Related Devices (Code: JJX)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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