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FDA 510(k)

TECHNICON DPA-1 IMMUNOGLOBULIN A

K-Number: K883492 · 1988-09-22

ApplicantTechnicon Instruments Corp.
Decision Date1988-09-22
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TECHNICON DPA-1 IMMUNOGLOBULIN A is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1988-09-22 under 510(k) number K883492. 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 TECHNICON DPA-1 IMMUNOGLOBULIN A?

TECHNICON DPA-1 IMMUNOGLOBULIN A is a medical device that received FDA 510(k) clearance on 1988-09-22. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K883492.

When did TECHNICON DPA-1 IMMUNOGLOBULIN A receive FDA 510(k) clearance?

TECHNICON DPA-1 IMMUNOGLOBULIN A received FDA 510(k) clearance on 1988-09-22, under 510(k) number K883492.

Who is the listed applicant for TECHNICON DPA-1 IMMUNOGLOBULIN A?

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

What is the FDA product code for TECHNICON DPA-1 IMMUNOGLOBULIN A?

The FDA product code for TECHNICON DPA-1 IMMUNOGLOBULIN A is CZP.

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Other records listing Technicon Instruments Corp. as applicant

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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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