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FDA 510(k)

ENZYME LINEARITY CONTROL

K-Number: K912718 · 1991-09-06

ApplicantPhoenix Diagnostics, Inc.
Decision Date1991-09-06
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYME LINEARITY CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-09-06 under 510(k) number K912718. 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 ENZYME LINEARITY CONTROL?

ENZYME LINEARITY CONTROL is a medical device that received FDA 510(k) clearance on 1991-09-06. The listed applicant is Phoenix Diagnostics, Inc.. The 510(k) number is K912718.

When did ENZYME LINEARITY CONTROL receive FDA 510(k) clearance?

ENZYME LINEARITY CONTROL received FDA 510(k) clearance on 1991-09-06, under 510(k) number K912718.

Who is the listed applicant for ENZYME LINEARITY CONTROL?

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

What is the FDA product code for ENZYME LINEARITY CONTROL?

The FDA product code for ENZYME LINEARITY CONTROL is JJY.

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Other records listing Phoenix 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.

K023268PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMSK020364PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMSK020148pHoenix ISE Reagents FOR Olympus AU Chemistry SystemsK020129PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULEK013451PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIESK012987PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER

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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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