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FDA 510(k)

N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000

K-Number: K003609 · 2001-05-16

ApplicantOsteometer Biotech A/S
Decision Date2001-05-16
Product CodeNEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 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 2001-05-16 under 510(k) number K003609. The device is classified under product code NEO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000?

N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 is a medical device that received FDA 510(k) clearance on 2001-05-16. The listed applicant is Osteometer Biotech A/S. The 510(k) number is K003609.

When did N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 receive FDA 510(k) clearance?

N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 received FDA 510(k) clearance on 2001-05-16, under 510(k) number K003609.

Who is the listed applicant for N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000?

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 N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000?

The FDA product code for N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 is NEO.

Related Clinical Trials

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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.

K990843SERUM CROSSLAPS ONE STEP ELISA

Related Devices (Code: NEO)

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.

K051297ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECKRoche Diagnostics Corp.

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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