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FDA 510(k)

CARCINO-CEK

K-Number: K823353 · 1982-12-14

ApplicantBiologics Intl., Inc.
Decision Date1982-12-14
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARCINO-CEK is the device name listed in this FDA 510(k) record. The listed applicant is Biologics Intl., Inc.. It received FDA 510(k) clearance on 1982-12-14 under 510(k) number K823353. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARCINO-CEK?

CARCINO-CEK is a medical device that received FDA 510(k) clearance on 1982-12-14. The listed applicant is Biologics Intl., Inc.. The 510(k) number is K823353.

When did CARCINO-CEK receive FDA 510(k) clearance?

CARCINO-CEK received FDA 510(k) clearance on 1982-12-14, under 510(k) number K823353.

Who is the listed applicant for CARCINO-CEK?

The FDA 510(k) record lists Biologics Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARCINO-CEK?

The FDA product code for CARCINO-CEK is JJX.

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Other records listing Biologics Intl., Inc. as applicant

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Related Devices (Code: JJX)

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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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