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FDA 510(k)

SYN ELISA BETA 2 MICROGLOBULIN TEST KIT

K-Number: K920132 · 1992-05-28

ApplicantElias U.S.A., Inc.
Decision Date1992-05-28
Product CodeJZG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SYN ELISA BETA 2 MICROGLOBULIN TEST KIT 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 1992-05-28 under 510(k) number K920132. 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 SYN ELISA BETA 2 MICROGLOBULIN TEST KIT?

SYN ELISA BETA 2 MICROGLOBULIN TEST KIT is a medical device that received FDA 510(k) clearance on 1992-05-28. The listed applicant is Elias U.S.A., Inc.. The 510(k) number is K920132.

When did SYN ELISA BETA 2 MICROGLOBULIN TEST KIT receive FDA 510(k) clearance?

SYN ELISA BETA 2 MICROGLOBULIN TEST KIT received FDA 510(k) clearance on 1992-05-28, under 510(k) number K920132.

Who is the listed applicant for SYN ELISA BETA 2 MICROGLOBULIN TEST KIT?

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 SYN ELISA BETA 2 MICROGLOBULIN TEST KIT?

The FDA product code for SYN ELISA BETA 2 MICROGLOBULIN TEST KIT is JZG.

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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: 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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