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FDA 510(k)

BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA

K-Number: K895496 · 1989-10-17

ApplicantIncstar Corp.
Decision Date1989-10-17
Product CodeJZG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA is the device name listed in this FDA 510(k) record. The listed applicant is Incstar Corp.. It received FDA 510(k) clearance on 1989-10-17 under 510(k) number K895496. The device is classified under product code JZG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA?

BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA is a medical device that received FDA 510(k) clearance on 1989-10-17. The listed applicant is Incstar Corp.. The 510(k) number is K895496.

When did BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA receive FDA 510(k) clearance?

BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA received FDA 510(k) clearance on 1989-10-17, under 510(k) number K895496.

Who is the listed applicant for BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA?

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 BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA?

The FDA product code for BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA is JZG.

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Other records listing Incstar Corp. 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.

K963289INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAYK963296INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)K963297INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)K960367INCSTAR RUBELLA IGG ELISA ASSAYK960358INCSTAR RUBELLA IGG FAST ELISA ASSAYK960434INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530

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Related Devices (Code: JZG)

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.

K161297Beta-2-MicroglobulinBeckman Coulter Ireland, Inc.K122066HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUSThe Binding Site Group , Ltd.K110874ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATORSiemens Healthcare Diagnostics, Inc.K083289HUMAN BETA-2 MICROGLOBULIN KITThe Binding Site, Ltd.K083463DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL MSiemens Healthcare DiagnosticsK072078QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307Biokit, S.A.

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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