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FDA 510(k)

DADE(R) TDM CONTROL

K-Number: K892642 · 1990-02-02

ApplicantBaxter Healthcare Corp
Decision Date1990-02-02
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DADE(R) TDM CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1990-02-02 under 510(k) number K892642. 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(R) TDM CONTROL?

DADE(R) TDM CONTROL is a medical device that received FDA 510(k) clearance on 1990-02-02. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K892642.

When did DADE(R) TDM CONTROL receive FDA 510(k) clearance?

DADE(R) TDM CONTROL received FDA 510(k) clearance on 1990-02-02, under 510(k) number K892642.

Who is the listed applicant for DADE(R) TDM CONTROL?

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

What is the FDA product code for DADE(R) TDM CONTROL?

The FDA product code for DADE(R) TDM CONTROL is JJY.

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Other records listing Baxter Healthcare 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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