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FDA 510(k)

B2-MICROGLOBULIN RADIOIMMUNOASSAY

K-Number: K920300 · 1992-03-17

ApplicantNichols Institute
Decision Date1992-03-17
Product CodeJZG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

B2-MICROGLOBULIN RADIOIMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute. It received FDA 510(k) clearance on 1992-03-17 under 510(k) number K920300. 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 B2-MICROGLOBULIN RADIOIMMUNOASSAY?

B2-MICROGLOBULIN RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1992-03-17. The listed applicant is Nichols Institute. The 510(k) number is K920300.

When did B2-MICROGLOBULIN RADIOIMMUNOASSAY receive FDA 510(k) clearance?

B2-MICROGLOBULIN RADIOIMMUNOASSAY received FDA 510(k) clearance on 1992-03-17, under 510(k) number K920300.

Who is the listed applicant for B2-MICROGLOBULIN RADIOIMMUNOASSAY?

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

What is the FDA product code for B2-MICROGLOBULIN RADIOIMMUNOASSAY?

The FDA product code for B2-MICROGLOBULIN RADIOIMMUNOASSAY is JZG.

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Other records listing Nichols Institute 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.

K952559ERYTHROPOIETIN IMMUNOASSAY KITK952505INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)K946247IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3K950524NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAYK932650ERYTHROPOIETIN IMMUNOASSAY KITK931600CHEMILUMINESCENCE FREE T3 IMMUNOASSAY

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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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