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FDA 510(k)

B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM

K-Number: K070310 · 2008-03-31

ApplicantBrahms Aktiengesellschaft
Decision Date2008-03-31
Product CodeNTM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Brahms Aktiengesellschaft. It received FDA 510(k) clearance on 2008-03-31 under 510(k) number K070310. The device is classified under product code NTM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM?

B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2008-03-31. The listed applicant is Brahms Aktiengesellschaft. The 510(k) number is K070310.

When did B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM receive FDA 510(k) clearance?

B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM received FDA 510(k) clearance on 2008-03-31, under 510(k) number K070310.

Who is the listed applicant for B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM?

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

What is the FDA product code for B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM?

The FDA product code for B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM is NTM.

Related Clinical Trials

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Other records listing Brahms Aktiengesellschaft 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.

K040887B-R-A-H-M-S PCT LIA

Related Devices (Code: NTM)

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.

K071146VIDAS B.R.A.H.M.S. PCT ASSAYbioMerieux, Inc.K040887B-R-A-H-M-S PCT LIABrahms Aktiengesellschaft

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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