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FDA 510(k)

PYRILINKS POLYCLONAL ASSAY KIT

K-Number: K952026 · 1995-11-03

ApplicantMetra Biosystems, Inc.
Decision Date1995-11-03
Product CodeJMM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PYRILINKS POLYCLONAL 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 1995-11-03 under 510(k) number K952026. The device is classified under product code JMM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PYRILINKS POLYCLONAL ASSAY KIT?

PYRILINKS POLYCLONAL ASSAY KIT is a medical device that received FDA 510(k) clearance on 1995-11-03. The listed applicant is Metra Biosystems, Inc.. The 510(k) number is K952026.

When did PYRILINKS POLYCLONAL ASSAY KIT receive FDA 510(k) clearance?

PYRILINKS POLYCLONAL ASSAY KIT received FDA 510(k) clearance on 1995-11-03, under 510(k) number K952026.

Who is the listed applicant for PYRILINKS POLYCLONAL 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 PYRILINKS POLYCLONAL ASSAY KIT?

The FDA product code for PYRILINKS POLYCLONAL ASSAY KIT is JMM.

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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 KITK952768ALKPHASE-B ASSAY KIT

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Related Devices (Code: JMM)

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.

K011052OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USEOstex Intl., Inc.K993706ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAYRoche Diagnostics Corp.K992997OSTEOMARK NTX POCMetrika, Inc.K990843SERUM CROSSLAPS ONE STEP ELISAOsteometer Biotech A/SK983457OSTEOMARK NTX SERUM EIAOstex Intl., Inc.K983674VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLSOrtho-Clinical Diagnostics, 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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