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FDA 510(k)

CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE

K-Number: K911755 · 1991-05-22

ApplicantBionostics, Inc.
Decision Date1991-05-22
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 1991-05-22 under 510(k) number K911755. 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 CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE?

CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE is a medical device that received FDA 510(k) clearance on 1991-05-22. The listed applicant is Bionostics, Inc.. The 510(k) number is K911755.

When did CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE receive FDA 510(k) clearance?

CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE received FDA 510(k) clearance on 1991-05-22, under 510(k) number K911755.

Who is the listed applicant for CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE?

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

What is the FDA product code for CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE?

The FDA product code for CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE is JJY.

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Other records listing Bionostics, Inc. 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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