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FDA 510(k)

EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA

K-Number: K921628 · 1992-09-14

ApplicantIncstar Corp.
Decision Date1992-09-14
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Incstar Corp.. It received FDA 510(k) clearance on 1992-09-14 under 510(k) number K921628. The device is classified under product code LSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA?

EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA is a medical device that received FDA 510(k) clearance on 1992-09-14. The listed applicant is Incstar Corp.. The 510(k) number is K921628.

When did EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA receive FDA 510(k) clearance?

EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA received FDA 510(k) clearance on 1992-09-14, under 510(k) number K921628.

Who is the listed applicant for EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA?

The FDA 510(k) record lists Incstar Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA?

The FDA product code for EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA is LSE.

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Other records listing Incstar Corp. as applicant

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K963289INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAYK963297INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)K963296INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)K960367INCSTAR RUBELLA IGG ELISA ASSAYK960358INCSTAR RUBELLA IGG FAST ELISA ASSAYK960434INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530

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Related Devices (Code: LSE)

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.

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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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