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FDA 510(k)

LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE)

K-Number: K853906 · 1985-10-04

ApplicantBiodiagnostic Intl
Decision Date1985-10-04
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) is the device name listed in this FDA 510(k) record. The listed applicant is Biodiagnostic Intl. It received FDA 510(k) clearance on 1985-10-04 under 510(k) number K853906. 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 LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE)?

LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) is a medical device that received FDA 510(k) clearance on 1985-10-04. The listed applicant is Biodiagnostic Intl. The 510(k) number is K853906.

When did LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) receive FDA 510(k) clearance?

LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) received FDA 510(k) clearance on 1985-10-04, under 510(k) number K853906.

Who is the listed applicant for LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE)?

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

What is the FDA product code for LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE)?

The FDA product code for LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) is JJY.

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Other records listing Biodiagnostic Intl 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.

K031296LIQUI-HEME GLYCO A1C ASSAYK881430LIQUI-SERA SERUM ALCOHOL CONTROLSK874459LIQUI-SERA SPINAL FLUID CONTROLK863849LIQUI-SERA COMBO LIGAND/TDM CONTROLSK853887LIQUI-SERA CHEM. MULTIPLE CALIBRATORSK842668LIQUI-HEME HEMOGLOBIN CALIBRATORS

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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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