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FDA 510(k)

RADIOASSY KIT, 3H-FOLATE

K-Number: K760262 · 1976-08-03

ApplicantDiamond Shamrock Corp.
Decision Date1976-08-03
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RADIOASSY KIT, 3H-FOLATE is the device name listed in this FDA 510(k) record. The listed applicant is Diamond Shamrock Corp.. It received FDA 510(k) clearance on 1976-08-03 under 510(k) number K760262. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOASSY KIT, 3H-FOLATE?

RADIOASSY KIT, 3H-FOLATE is a medical device that received FDA 510(k) clearance on 1976-08-03. The listed applicant is Diamond Shamrock Corp.. The 510(k) number is K760262.

When did RADIOASSY KIT, 3H-FOLATE receive FDA 510(k) clearance?

RADIOASSY KIT, 3H-FOLATE received FDA 510(k) clearance on 1976-08-03, under 510(k) number K760262.

Who is the listed applicant for RADIOASSY KIT, 3H-FOLATE?

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

What is the FDA product code for RADIOASSY KIT, 3H-FOLATE?

The FDA product code for RADIOASSY KIT, 3H-FOLATE is CGN.

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Other records listing Diamond Shamrock Corp. 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.

K830197TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS

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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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