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FDA 510(k)

SYNELISA PARIETAL CELL ANTIBODIES

K-Number: K930422 · 1993-08-03

ApplicantElias U.S.A., Inc.
Decision Date1993-08-03
Product CodeDBJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SYNELISA PARIETAL CELL 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 1993-08-03 under 510(k) number K930422. The device is classified under product code DBJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNELISA PARIETAL CELL ANTIBODIES?

SYNELISA PARIETAL CELL ANTIBODIES is a medical device that received FDA 510(k) clearance on 1993-08-03. The listed applicant is Elias U.S.A., Inc.. The 510(k) number is K930422.

When did SYNELISA PARIETAL CELL ANTIBODIES receive FDA 510(k) clearance?

SYNELISA PARIETAL CELL ANTIBODIES received FDA 510(k) clearance on 1993-08-03, under 510(k) number K930422.

Who is the listed applicant for SYNELISA PARIETAL CELL 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 PARIETAL CELL ANTIBODIES?

The FDA product code for SYNELISA PARIETAL CELL ANTIBODIES is DBJ.

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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: DBJ)

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.

K790759IIF-APCA TEST KITMedica Corp.

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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