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FDA 510(k)

OSTEOMARK NTX POC

K-Number: K992997 · 1999-11-09

ApplicantMetrika, Inc.
Decision Date1999-11-09
Product CodeJMM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OSTEOMARK NTX POC is the device name listed in this FDA 510(k) record. The listed applicant is Metrika, Inc.. It received FDA 510(k) clearance on 1999-11-09 under 510(k) number K992997. 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 OSTEOMARK NTX POC?

OSTEOMARK NTX POC is a medical device that received FDA 510(k) clearance on 1999-11-09. The listed applicant is Metrika, Inc.. The 510(k) number is K992997.

When did OSTEOMARK NTX POC receive FDA 510(k) clearance?

OSTEOMARK NTX POC received FDA 510(k) clearance on 1999-11-09, under 510(k) number K992997.

Who is the listed applicant for OSTEOMARK NTX POC?

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

What is the FDA product code for OSTEOMARK NTX POC?

The FDA product code for OSTEOMARK NTX POC is JMM.

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Other records listing Metrika, 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.

K051321INVIEWK033847A1CNOW FOR HOME AND PROFESSIONAL USEK022661A1CNOW FOR HOME USEK020235A1CNOW FOR PROFESSIONAL USEK020234A1CNOW FOR RX HOME USEK000885DRX HBA1C - FOR PRESCRIPTION HOME USE

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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.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.K972788CROSSLAPS ELISADevices and Diagnostics Consulting Group

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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