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FDA 510(k)

DC-TROL LEVEL 1 OR 2

K-Number: K874772 · 1988-01-05

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1988-01-05
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DC-TROL LEVEL 1 OR 2 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1988-01-05 under 510(k) number K874772. 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 DC-TROL LEVEL 1 OR 2?

DC-TROL LEVEL 1 OR 2 is a medical device that received FDA 510(k) clearance on 1988-01-05. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K874772.

When did DC-TROL LEVEL 1 OR 2 receive FDA 510(k) clearance?

DC-TROL LEVEL 1 OR 2 received FDA 510(k) clearance on 1988-01-05, under 510(k) number K874772.

Who is the listed applicant for DC-TROL LEVEL 1 OR 2?

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

What is the FDA product code for DC-TROL LEVEL 1 OR 2?

The FDA product code for DC-TROL LEVEL 1 OR 2 is JJY.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

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Related Devices (Code: JJY)

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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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