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FDA 510(k)

ANALYZER: STAT PROFILE PLUS 10 ANALYZER

K-Number: K931373 · 1993-06-15

ApplicantNova Biomedical Corp.
Decision Date1993-06-15
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ANALYZER: STAT PROFILE PLUS 10 ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Nova Biomedical Corp.. It received FDA 510(k) clearance on 1993-06-15 under 510(k) number K931373. 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 ANALYZER: STAT PROFILE PLUS 10 ANALYZER?

ANALYZER: STAT PROFILE PLUS 10 ANALYZER is a medical device that received FDA 510(k) clearance on 1993-06-15. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K931373.

When did ANALYZER: STAT PROFILE PLUS 10 ANALYZER receive FDA 510(k) clearance?

ANALYZER: STAT PROFILE PLUS 10 ANALYZER received FDA 510(k) clearance on 1993-06-15, under 510(k) number K931373.

Who is the listed applicant for ANALYZER: STAT PROFILE PLUS 10 ANALYZER?

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

What is the FDA product code for ANALYZER: STAT PROFILE PLUS 10 ANALYZER?

The FDA product code for ANALYZER: STAT PROFILE PLUS 10 ANALYZER is JJY.

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Other records listing Nova Biomedical Corp. 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.

K100602NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPSK101633NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGHK091547NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOSK070960NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEMK070255NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002K070068NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS

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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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