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FDA 510(k)

ALKPHASE-B ASSAY KIT

K-Number: K952768 · 1995-08-24

ApplicantMetra Biosystems, Inc.
Decision Date1995-08-24
Product CodeCIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKPHASE-B ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Metra Biosystems, Inc.. It received FDA 510(k) clearance on 1995-08-24 under 510(k) number K952768. 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 ALKPHASE-B ASSAY KIT?

ALKPHASE-B ASSAY KIT is a medical device that received FDA 510(k) clearance on 1995-08-24. The listed applicant is Metra Biosystems, Inc.. The 510(k) number is K952768.

When did ALKPHASE-B ASSAY KIT receive FDA 510(k) clearance?

ALKPHASE-B ASSAY KIT received FDA 510(k) clearance on 1995-08-24, under 510(k) number K952768.

Who is the listed applicant for ALKPHASE-B ASSAY KIT?

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

What is the FDA product code for ALKPHASE-B ASSAY KIT?

The FDA product code for ALKPHASE-B ASSAY KIT is CIN.

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Other records listing Metra Biosystems, 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.

K981364PYRILINKS-D ASSAY KITK981373ALKPHASE-B ASSAY KITK974260PYRILINKS-D ASSAY KITK952320PYRILINKS-D ASSAY KITK952506PYRILINKS ASSAY KITK952026PYRILINKS POLYCLONAL ASSAY KIT

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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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