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FDA 510(k)

MONI-TRO ES CHEMISTRY CONTROL LEVEL IX

K-Number: K822850 · 1982-10-27

ApplicantAmerican Dade
Decision Date1982-10-27
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MONI-TRO ES CHEMISTRY CONTROL LEVEL IX is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1982-10-27 under 510(k) number K822850. 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 MONI-TRO ES CHEMISTRY CONTROL LEVEL IX?

MONI-TRO ES CHEMISTRY CONTROL LEVEL IX is a medical device that received FDA 510(k) clearance on 1982-10-27. The listed applicant is American Dade. The 510(k) number is K822850.

When did MONI-TRO ES CHEMISTRY CONTROL LEVEL IX receive FDA 510(k) clearance?

MONI-TRO ES CHEMISTRY CONTROL LEVEL IX received FDA 510(k) clearance on 1982-10-27, under 510(k) number K822850.

Who is the listed applicant for MONI-TRO ES CHEMISTRY CONTROL LEVEL IX?

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

What is the FDA product code for MONI-TRO ES CHEMISTRY CONTROL LEVEL IX?

The FDA product code for MONI-TRO ES CHEMISTRY CONTROL LEVEL IX is JJY.

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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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