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FDA 510(k)

SERUM CROSSLAPS ONE STEP ELISA

K-Number: K990843 · 1999-07-09

ApplicantOsteometer Biotech A/S
Decision Date1999-07-09
Product CodeJMM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM CROSSLAPS ONE STEP ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Osteometer Biotech A/S. It received FDA 510(k) clearance on 1999-07-09 under 510(k) number K990843. 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 SERUM CROSSLAPS ONE STEP ELISA?

SERUM CROSSLAPS ONE STEP ELISA is a medical device that received FDA 510(k) clearance on 1999-07-09. The listed applicant is Osteometer Biotech A/S. The 510(k) number is K990843.

When did SERUM CROSSLAPS ONE STEP ELISA receive FDA 510(k) clearance?

SERUM CROSSLAPS ONE STEP ELISA received FDA 510(k) clearance on 1999-07-09, under 510(k) number K990843.

Who is the listed applicant for SERUM CROSSLAPS ONE STEP ELISA?

The FDA 510(k) record lists Osteometer Biotech A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERUM CROSSLAPS ONE STEP ELISA?

The FDA product code for SERUM CROSSLAPS ONE STEP ELISA is JMM.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Osteometer Biotech A/S 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.

K003609N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000

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.K983457OSTEOMARK 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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