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FDA 510(k)

ENTERIC 20

K-Number: K771703 · 1977-10-04

ApplicantInolex Corp./Div of Biomedical
Decision Date1977-10-04
Product CodeJSS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENTERIC 20 is the device name listed in this FDA 510(k) record. The listed applicant is Inolex Corp./Div of Biomedical. It received FDA 510(k) clearance on 1977-10-04 under 510(k) number K771703. The device is classified under product code JSS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTERIC 20?

ENTERIC 20 is a medical device that received FDA 510(k) clearance on 1977-10-04. The listed applicant is Inolex Corp./Div of Biomedical. The 510(k) number is K771703.

When did ENTERIC 20 receive FDA 510(k) clearance?

ENTERIC 20 received FDA 510(k) clearance on 1977-10-04, under 510(k) number K771703.

Who is the listed applicant for ENTERIC 20?

The FDA 510(k) record lists Inolex Corp./Div of Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENTERIC 20?

The FDA product code for ENTERIC 20 is JSS.

Related Clinical Trials

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Other records listing Inolex Corp./Div of Biomedical 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.

K802563TRANSETTE SYSTEM/COLLECTION & TRANSP

Related Devices (Code: JSS)

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.

K123418GRAM-NEGATIVE QUICKFISH BCAdvandx, Inc.K101558GNR TRAFFIC LIGHT PNA FISHAdvandx, Inc.K092236E.COLI/P. AERUGINOSA PNA FISHAdvandx, Inc.K092393EK/P. AERUGINOSA PNA FISHAdvandx, Inc.K082068E. COLI PNA FISHAdvandx, Inc.K081433EK/P. AERUGINOSA PNA FISHAdvandx, Inc.

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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