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FDA 510(k)

DIASTAT ANTI-LA (SS-B)

K-Number: K905193 · 1990-12-13

ApplicantShield Diagnostics, Ltd.
Decision Date1990-12-13
Product CodeLKO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIASTAT ANTI-LA (SS-B) 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 1990-12-13 under 510(k) number K905193. The device is classified under product code LKO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIASTAT ANTI-LA (SS-B)?

DIASTAT ANTI-LA (SS-B) is a medical device that received FDA 510(k) clearance on 1990-12-13. The listed applicant is Shield Diagnostics, Ltd.. The 510(k) number is K905193.

When did DIASTAT ANTI-LA (SS-B) receive FDA 510(k) clearance?

DIASTAT ANTI-LA (SS-B) received FDA 510(k) clearance on 1990-12-13, under 510(k) number K905193.

Who is the listed applicant for DIASTAT ANTI-LA (SS-B)?

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 ANTI-LA (SS-B)?

The FDA product code for DIASTAT ANTI-LA (SS-B) is LKO.

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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: LKO)

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.

K191085Maverick RNP Assay and Maverick Diagnostic SystemGenalyte, Inc.K123261EUROIMMUN ANTI-NRNP/SM ELISA (IGG)Euroimmun USK083117ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01Phadia US, Inc.K071210MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006Biomedical Diagnostics (Bmd) SAK022017RHIGENE MESACUP-2 TEST RNP, MODEL M7741Rhigene, Inc.K000752RHIGENE MESACUP2 TEST- RNPRhigene, Inc.

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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