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FDA 510(k)

TANDEM-E IGE II CALIBRATION VERIFICATION SET

K-Number: K922754 · 1993-02-17

ApplicantHybritech, Inc.
Decision Date1993-02-17
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TANDEM-E IGE II CALIBRATION VERIFICATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Hybritech, Inc.. It received FDA 510(k) clearance on 1993-02-17 under 510(k) number K922754. 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 IGE II CALIBRATION VERIFICATION SET?

TANDEM-E IGE II CALIBRATION VERIFICATION SET is a medical device that received FDA 510(k) clearance on 1993-02-17. The listed applicant is Hybritech, Inc.. The 510(k) number is K922754.

When did TANDEM-E IGE II CALIBRATION VERIFICATION SET receive FDA 510(k) clearance?

TANDEM-E IGE II CALIBRATION VERIFICATION SET received FDA 510(k) clearance on 1993-02-17, under 510(k) number K922754.

Who is the listed applicant for TANDEM-E IGE II CALIBRATION VERIFICATION SET?

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 IGE II CALIBRATION VERIFICATION SET?

The FDA product code for TANDEM-E IGE II CALIBRATION VERIFICATION SET is JJX.

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Other records listing Hybritech, Inc. as applicant

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K972666TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAYK961573TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK930810TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNOK921252TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROLK920556TANDEM-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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