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FDA 510(k)

DADE URINE CHEMISTRY CONTROL LEVELS I AND II

K-Number: K920636 · 1992-07-07

ApplicantBaxter Diagnostics, Inc.
Decision Date1992-07-07
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DADE URINE CHEMISTRY CONTROL LEVELS I AND II is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-07-07 under 510(k) number K920636. 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 URINE CHEMISTRY CONTROL LEVELS I AND II?

DADE URINE CHEMISTRY CONTROL LEVELS I AND II is a medical device that received FDA 510(k) clearance on 1992-07-07. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K920636.

When did DADE URINE CHEMISTRY CONTROL LEVELS I AND II receive FDA 510(k) clearance?

DADE URINE CHEMISTRY CONTROL LEVELS I AND II received FDA 510(k) clearance on 1992-07-07, under 510(k) number K920636.

Who is the listed applicant for DADE URINE CHEMISTRY CONTROL LEVELS I AND II?

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

What is the FDA product code for DADE URINE CHEMISTRY CONTROL LEVELS I AND II?

The FDA product code for DADE URINE CHEMISTRY CONTROL LEVELS I AND II is JJY.

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Other records listing Baxter Diagnostics, Inc. 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)

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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