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FDA 510(k)

ORGENTEC ENASCREEN PIN IMMUNO ASSAY

K-Number: K955133 · 1996-03-20

ApplicantOrgentec
Decision Date1996-03-20
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ORGENTEC ENASCREEN PIN IMMUNO ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Orgentec. It received FDA 510(k) clearance on 1996-03-20 under 510(k) number K955133. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORGENTEC ENASCREEN PIN IMMUNO ASSAY?

ORGENTEC ENASCREEN PIN IMMUNO ASSAY is a medical device that received FDA 510(k) clearance on 1996-03-20. The listed applicant is Orgentec. The 510(k) number is K955133.

When did ORGENTEC ENASCREEN PIN IMMUNO ASSAY receive FDA 510(k) clearance?

ORGENTEC ENASCREEN PIN IMMUNO ASSAY received FDA 510(k) clearance on 1996-03-20, under 510(k) number K955133.

Who is the listed applicant for ORGENTEC ENASCREEN PIN IMMUNO ASSAY?

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

What is the FDA product code for ORGENTEC ENASCREEN PIN IMMUNO ASSAY?

The FDA product code for ORGENTEC ENASCREEN PIN IMMUNO ASSAY is LLL.

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Other records listing Orgentec 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.

K954831ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAYK954830ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAYK954815ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAYK954829ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAYK954814ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAYK954832ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY

View all 10 devices →

Related Devices (Code: LLL)

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.

K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems LimitedK253367EliA CTD 13 ScreenPhadia ABK250666Alegria Flash CTD ScreenZeus ScientificK250408Alegria Flash ENA ScreenZeus ScientificK213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.K190710EliA SymphonyS ImmunoassayPhadia AB

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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