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FDA 510(k)

IMMUNOGLOBULINS A

K-Number: K873869 · 1987-10-13

ApplicantUnipath , Ltd.
Decision Date1987-10-13
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOGLOBULINS A is the device name listed in this FDA 510(k) record. The listed applicant is Unipath , Ltd.. It received FDA 510(k) clearance on 1987-10-13 under 510(k) number K873869. The device is classified under product code CZP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOGLOBULINS A?

IMMUNOGLOBULINS A is a medical device that received FDA 510(k) clearance on 1987-10-13. The listed applicant is Unipath , Ltd.. The 510(k) number is K873869.

When did IMMUNOGLOBULINS A receive FDA 510(k) clearance?

IMMUNOGLOBULINS A received FDA 510(k) clearance on 1987-10-13, under 510(k) number K873869.

Who is the listed applicant for IMMUNOGLOBULINS A?

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

What is the FDA product code for IMMUNOGLOBULINS A?

The FDA product code for IMMUNOGLOBULINS A is CZP.

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Other records listing Unipath , Ltd. 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.

K061769E.P.T. CERTAINTY 1-STEP PREGNANCY TESTK060128CLEARBLUE EASY DIGITAL PREGNANCY TESTK051638INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBCK050930E.P.T. CERTAINTY PREGNANCY TESTK042280FACT PLUS ONE-STEP PREGNANCY TEST KITK041404CLEARBLUE EASY EASY READ PREGNANCY TEST

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Related Devices (Code: CZP)

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.

K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MHORIBA ABX SASK060130IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENTBeckman Coulter, Inc.K040435ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2Roche Diagnostics Corp.K024038N LATEX IGADade Behring, Inc.K993927WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRADWako Chemicals USA, Inc.K983359IGAAbbott Laboratories

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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