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FDA 510(k)

CALIBRATION VERIFICATION KIT OR CVK

K-Number: K924802 · 1993-03-09

ApplicantRadiometer America, Inc.
Decision Date1993-03-09
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALIBRATION VERIFICATION KIT OR CVK is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer America, Inc.. It received FDA 510(k) clearance on 1993-03-09 under 510(k) number K924802. 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 CALIBRATION VERIFICATION KIT OR CVK?

CALIBRATION VERIFICATION KIT OR CVK is a medical device that received FDA 510(k) clearance on 1993-03-09. The listed applicant is Radiometer America, Inc.. The 510(k) number is K924802.

When did CALIBRATION VERIFICATION KIT OR CVK receive FDA 510(k) clearance?

CALIBRATION VERIFICATION KIT OR CVK received FDA 510(k) clearance on 1993-03-09, under 510(k) number K924802.

Who is the listed applicant for CALIBRATION VERIFICATION KIT OR CVK?

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

What is the FDA product code for CALIBRATION VERIFICATION KIT OR CVK?

The FDA product code for CALIBRATION VERIFICATION KIT OR CVK is JJY.

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Other records listing Radiometer America, 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.

K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitK992859ABL700 SERIES ANALYZER WITH AUTOCHECK MODULEK991417ABL 735 ANALYZERK982928NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEMK980130ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEMK980135QUALICHECK5+ MODELS S7730, S7740, S7750, S7760

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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