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FDA 510(k)

DIASTAT ENA SINGLE WELL SCREEN KIT

K-Number: K944505 · 1994-11-21

ApplicantShield Diagnostics, Ltd.
Decision Date1994-11-21
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIASTAT ENA SINGLE WELL SCREEN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Shield Diagnostics, Ltd.. It received FDA 510(k) clearance on 1994-11-21 under 510(k) number K944505. 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 DIASTAT ENA SINGLE WELL SCREEN KIT?

DIASTAT ENA SINGLE WELL SCREEN KIT is a medical device that received FDA 510(k) clearance on 1994-11-21. The listed applicant is Shield Diagnostics, Ltd.. The 510(k) number is K944505.

When did DIASTAT ENA SINGLE WELL SCREEN KIT receive FDA 510(k) clearance?

DIASTAT ENA SINGLE WELL SCREEN KIT received FDA 510(k) clearance on 1994-11-21, under 510(k) number K944505.

Who is the listed applicant for DIASTAT ENA SINGLE WELL SCREEN KIT?

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

What is the FDA product code for DIASTAT ENA SINGLE WELL SCREEN KIT?

The FDA product code for DIASTAT ENA SINGLE WELL SCREEN KIT is LLL.

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Other records listing Shield Diagnostics, Ltd. 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.

K000398SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200K982879SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAYK980885SHIELD ACTIVATED FACTOR XII (ELISA) ASSAYK972981SHIELD HELICO-G2 ELISA KITK962825SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAYK963525DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT

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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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