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FDA 510(k)

TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY

K-Number: K870521 · 1987-04-08

ApplicantHybritech, Inc.
Decision Date1987-04-08
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Hybritech, Inc.. It received FDA 510(k) clearance on 1987-04-08 under 510(k) number K870521. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY?

TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY is a medical device that received FDA 510(k) clearance on 1987-04-08. The listed applicant is Hybritech, Inc.. The 510(k) number is K870521.

When did TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY receive FDA 510(k) clearance?

TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY received FDA 510(k) clearance on 1987-04-08, under 510(k) number K870521.

Who is the listed applicant for TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY?

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(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY?

The FDA product code for TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY is JHI.

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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 IMMUNOK921252TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL

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Related Devices (Code: JHI)

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.

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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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