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FDA 510(k)

CRITIC C LEVEL I & II

K-Number: K853943 · 1985-12-23

ApplicantDimension Diagnostics
Decision Date1985-12-23
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CRITIC C LEVEL I & II is the device name listed in this FDA 510(k) record. The listed applicant is Dimension Diagnostics. It received FDA 510(k) clearance on 1985-12-23 under 510(k) number K853943. 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 CRITIC C LEVEL I & II?

CRITIC C LEVEL I & II is a medical device that received FDA 510(k) clearance on 1985-12-23. The listed applicant is Dimension Diagnostics. The 510(k) number is K853943.

When did CRITIC C LEVEL I & II receive FDA 510(k) clearance?

CRITIC C LEVEL I & II received FDA 510(k) clearance on 1985-12-23, under 510(k) number K853943.

Who is the listed applicant for CRITIC C LEVEL I & II?

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

What is the FDA product code for CRITIC C LEVEL I & II?

The FDA product code for CRITIC C LEVEL I & II is JJY.

Related Clinical Trials

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.

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Other records listing Dimension Diagnostics 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.

K863223DIMENSION-WBGK861366ALT-30, 60 AND 100K854967CRITIC - SF, ASSAYEDK852295UROL-GUANTK844848IMA-TROL IMMUNOASSAY CONTROLK844709CRITIC-ARS

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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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