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FDA 510(k)

SYLNELISA HISTONE ANTIBODIES

K-Number: K932302 · 1993-08-23

ApplicantElias U.S.A., Inc.
Decision Date1993-08-23
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SYLNELISA HISTONE 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 1993-08-23 under 510(k) number K932302. 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 SYLNELISA HISTONE ANTIBODIES?

SYLNELISA HISTONE ANTIBODIES is a medical device that received FDA 510(k) clearance on 1993-08-23. The listed applicant is Elias U.S.A., Inc.. The 510(k) number is K932302.

When did SYLNELISA HISTONE ANTIBODIES receive FDA 510(k) clearance?

SYLNELISA HISTONE ANTIBODIES received FDA 510(k) clearance on 1993-08-23, under 510(k) number K932302.

Who is the listed applicant for SYLNELISA HISTONE 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 SYLNELISA HISTONE ANTIBODIES?

The FDA product code for SYLNELISA HISTONE 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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