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FDA 510(k)

NA ALPHA 1 MICROGLOBULIN KIT

K-Number: K904254 · 1991-04-05

ApplicantBehring Diagnostics, Inc.
Decision Date1991-04-05
Product CodeJZG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NA ALPHA 1 MICROGLOBULIN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-04-05 under 510(k) number K904254. 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 NA ALPHA 1 MICROGLOBULIN KIT?

NA ALPHA 1 MICROGLOBULIN KIT is a medical device that received FDA 510(k) clearance on 1991-04-05. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K904254.

When did NA ALPHA 1 MICROGLOBULIN KIT receive FDA 510(k) clearance?

NA ALPHA 1 MICROGLOBULIN KIT received FDA 510(k) clearance on 1991-04-05, under 510(k) number K904254.

Who is the listed applicant for NA ALPHA 1 MICROGLOBULIN KIT?

The FDA 510(k) record lists Behring Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NA ALPHA 1 MICROGLOBULIN KIT?

The FDA product code for NA ALPHA 1 MICROGLOBULIN KIT is JZG.

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Other records listing Behring Diagnostics, Inc. as applicant

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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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