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FDA 510(k)

TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY

K-Number: K972666 · 1997-09-11

ApplicantHybritech, Inc.
Decision Date1997-09-11
Product CodeCIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TANDEM-MP OSTASE IMMUNOENZYMETRIC 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 1997-09-11 under 510(k) number K972666. The device is classified under product code CIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY?

TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1997-09-11. The listed applicant is Hybritech, Inc.. The 510(k) number is K972666.

When did TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY receive FDA 510(k) clearance?

TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY received FDA 510(k) clearance on 1997-09-11, under 510(k) number K972666.

Who is the listed applicant for TANDEM-MP OSTASE IMMUNOENZYMETRIC 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-MP OSTASE IMMUNOENZYMETRIC ASSAY?

The FDA product code for TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY is CIN.

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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.

K961573TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK930810TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK922754TANDEM-E IGE II CALIBRATION VERIFICATION SETK921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNOK921252TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROLK920556TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET

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Related Devices (Code: CIN)

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.

K232904Access OstaseBeckman CoulterK200475IDS-iSYS Ostase BAPImmunodiagnostic Systems , Ltd.K043125ORION DIAGNOSTICA UNIQ PINP RIAOrion Diagnostica, OYK020625SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346Helena LaboratoriesK011113HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)SebiaK994278ACCESS OSTASE IMMUNOENZYMETRIC ASSAYBeckman Coulter, Inc.

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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