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FDA 510(k)

TUMOR MARKER CONTROL

K-Number: K965114 · 1997-02-20

ApplicantDiagnostic Products Corp.
Decision Date1997-02-20
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TUMOR MARKER CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1997-02-20 under 510(k) number K965114. 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 TUMOR MARKER CONTROL?

TUMOR MARKER CONTROL is a medical device that received FDA 510(k) clearance on 1997-02-20. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K965114.

When did TUMOR MARKER CONTROL receive FDA 510(k) clearance?

TUMOR MARKER CONTROL received FDA 510(k) clearance on 1997-02-20, under 510(k) number K965114.

Who is the listed applicant for TUMOR MARKER CONTROL?

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

What is the FDA product code for TUMOR MARKER CONTROL?

The FDA product code for TUMOR MARKER CONTROL is JJY.

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Other records listing Diagnostic Products Corp. as applicant

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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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