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FDA 510(k)

IMMUNO DIAGNOSTICS ASSAY

K-Number: K822026 · 1982-08-03

ApplicantHelena Laboratories
Decision Date1982-08-03
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNO DIAGNOSTICS ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1982-08-03 under 510(k) number K822026. 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 IMMUNO DIAGNOSTICS ASSAY?

IMMUNO DIAGNOSTICS ASSAY is a medical device that received FDA 510(k) clearance on 1982-08-03. The listed applicant is Helena Laboratories. The 510(k) number is K822026.

When did IMMUNO DIAGNOSTICS ASSAY receive FDA 510(k) clearance?

IMMUNO DIAGNOSTICS ASSAY received FDA 510(k) clearance on 1982-08-03, under 510(k) number K822026.

Who is the listed applicant for IMMUNO DIAGNOSTICS ASSAY?

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

What is the FDA product code for IMMUNO DIAGNOSTICS ASSAY?

The FDA product code for IMMUNO DIAGNOSTICS ASSAY is CZP.

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Other records listing Helena Laboratories 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.

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

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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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