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FDA 510(k)

SERUM VOLATILES CONTROL - LEVELS 1 AND 2

K-Number: K941698 · 1994-07-28

ApplicantMore Diagnostics
Decision Date1994-07-28
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM VOLATILES CONTROL - LEVELS 1 AND 2 is the device name listed in this FDA 510(k) record. The listed applicant is More Diagnostics. It received FDA 510(k) clearance on 1994-07-28 under 510(k) number K941698. 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 SERUM VOLATILES CONTROL - LEVELS 1 AND 2?

SERUM VOLATILES CONTROL - LEVELS 1 AND 2 is a medical device that received FDA 510(k) clearance on 1994-07-28. The listed applicant is More Diagnostics. The 510(k) number is K941698.

When did SERUM VOLATILES CONTROL - LEVELS 1 AND 2 receive FDA 510(k) clearance?

SERUM VOLATILES CONTROL - LEVELS 1 AND 2 received FDA 510(k) clearance on 1994-07-28, under 510(k) number K941698.

Who is the listed applicant for SERUM VOLATILES CONTROL - LEVELS 1 AND 2?

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

What is the FDA product code for SERUM VOLATILES CONTROL - LEVELS 1 AND 2?

The FDA product code for SERUM VOLATILES CONTROL - LEVELS 1 AND 2 is JJY.

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Other records listing More Diagnostics 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.

K072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELK050125RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4K982845CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3K980331IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\SK972976CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVELK970778LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4

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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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