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FDA 510(k)

VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96

K-Number: K993108 · 1999-11-12

ApplicantPharmacia & Upjohn Co.
Decision Date1999-11-12
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia & Upjohn Co.. It received FDA 510(k) clearance on 1999-11-12 under 510(k) number K993108. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96?

VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 is a medical device that received FDA 510(k) clearance on 1999-11-12. The listed applicant is Pharmacia & Upjohn Co.. The 510(k) number is K993108.

When did VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 receive FDA 510(k) clearance?

VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 received FDA 510(k) clearance on 1999-11-12, under 510(k) number K993108.

Who is the listed applicant for VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96?

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

What is the FDA product code for VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96?

The FDA product code for VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 is LJM.

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Other records listing Pharmacia & Upjohn Co. 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.

K003414VARELISA TG (THYROGLOBULIN) ANTIBODIES,K002556CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1K000312VARELISA SM ANTIBODIESK000132ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8K993585VARELISA TPO ANTIBODIES, MODEL 12348/12396K993388ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F

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Related Devices (Code: LJM)

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.

K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia ABK151559ImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.K131185ANA SCREEN ELISA (IGG)Euroimmun USK083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596Phadia US, Inc.K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbHK050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbH

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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