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FDA 510(k)

SYNELISA CENP-B ANTIBODIES

K-Number: K931255 · 1993-09-24

ApplicantElias U.S.A., Inc.
Decision Date1993-09-24
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SYNELISA CENP-B ANTIBODIES is the device name listed in this FDA 510(k) record. The listed applicant is Elias U.S.A., Inc.. It received FDA 510(k) clearance on 1993-09-24 under 510(k) number K931255. The device is classified under product code LKJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNELISA CENP-B ANTIBODIES?

SYNELISA CENP-B ANTIBODIES is a medical device that received FDA 510(k) clearance on 1993-09-24. The listed applicant is Elias U.S.A., Inc.. The 510(k) number is K931255.

When did SYNELISA CENP-B ANTIBODIES receive FDA 510(k) clearance?

SYNELISA CENP-B ANTIBODIES received FDA 510(k) clearance on 1993-09-24, under 510(k) number K931255.

Who is the listed applicant for SYNELISA CENP-B ANTIBODIES?

The FDA 510(k) record lists Elias U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNELISA CENP-B ANTIBODIES?

The FDA product code for SYNELISA CENP-B ANTIBODIES is LKJ.

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Other records listing Elias U.S.A., Inc. 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.

K964385ELIAS ANA-HEP-2K963291VARELISA ANA (4) PROFILEK953873VARELISA HELICOBACTER PYLORI ANTIBODIESK953587VARELISA MPO-ANCAK953586VARELISA PR3-ANCAK951187VARELISA CARDIOLIPIN ABS SCREEN

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Related Devices (Code: LKJ)

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.

K210902EliA Ro52, EliA Ro60Phadia ABK113610ANA-SCREEN WITH MDSSBio-Rad LaboratoriesK082759ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAYPhadia US, Inc.K081104AESKULISA ANA HEP-2, REF 30-7115USAesku DiagnosticsK041658BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200Bio-Rad Laboratories, Inc.K042416ATHENA MULTI-LYTE ANA-II TEST SYSTEMZeus Scientific, 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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