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FDA 510(k)

DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO

K-Number: K850574 · 1985-04-12

ApplicantAmerican Dade
Decision Date1985-04-12
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1985-04-12 under 510(k) number K850574. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO?

DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO is a medical device that received FDA 510(k) clearance on 1985-04-12. The listed applicant is American Dade. The 510(k) number is K850574.

When did DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO receive FDA 510(k) clearance?

DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO received FDA 510(k) clearance on 1985-04-12, under 510(k) number K850574.

Who is the listed applicant for DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO?

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

What is the FDA product code for DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO?

The FDA product code for DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO is JJY.

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Related Devices (Code: JJY)

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.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad LaboratoriesK153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

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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