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FDA 510(k)

MCDB 151 MEDIUM, PRODUCT NO. M6645

K-Number: K851607 · 1985-05-15

Decision Date1985-05-15
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MCDB 151 MEDIUM, PRODUCT NO. M6645 is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1985-05-15 under 510(k) number K851607. The device is classified under product code KIT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCDB 151 MEDIUM, PRODUCT NO. M6645?

MCDB 151 MEDIUM, PRODUCT NO. M6645 is a medical device that received FDA 510(k) clearance on 1985-05-15. The listed applicant is Sigma Chemical Co.. The 510(k) number is K851607.

When did MCDB 151 MEDIUM, PRODUCT NO. M6645 receive FDA 510(k) clearance?

MCDB 151 MEDIUM, PRODUCT NO. M6645 received FDA 510(k) clearance on 1985-05-15, under 510(k) number K851607.

Who is the listed applicant for MCDB 151 MEDIUM, PRODUCT NO. M6645?

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

What is the FDA product code for MCDB 151 MEDIUM, PRODUCT NO. M6645?

The FDA product code for MCDB 151 MEDIUM, PRODUCT NO. M6645 is KIT.

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.

Other records listing Sigma Chemical Co. 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.

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Related Devices (Code: KIT)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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