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FDA 510(k)

SERUM VOLATILES CONTROL LEVEL 1 & 2

K-Number: K955691 · 1996-04-24

ApplicantClinical Controls, Inc.
Decision Date1996-04-24
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM VOLATILES CONTROL LEVEL 1 & 2 is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Controls, Inc.. It received FDA 510(k) clearance on 1996-04-24 under 510(k) number K955691. 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 LEVEL 1 & 2?

SERUM VOLATILES CONTROL LEVEL 1 & 2 is a medical device that received FDA 510(k) clearance on 1996-04-24. The listed applicant is Clinical Controls, Inc.. The 510(k) number is K955691.

When did SERUM VOLATILES CONTROL LEVEL 1 & 2 receive FDA 510(k) clearance?

SERUM VOLATILES CONTROL LEVEL 1 & 2 received FDA 510(k) clearance on 1996-04-24, under 510(k) number K955691.

Who is the listed applicant for SERUM VOLATILES CONTROL LEVEL 1 & 2?

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

What is the FDA product code for SERUM VOLATILES CONTROL LEVEL 1 & 2?

The FDA product code for SERUM VOLATILES CONTROL LEVEL 1 & 2 is JJY.

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Other records listing Clinical Controls, 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.

K964278WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6K962432LIQUISPEX URINE (MICRO)ALBUMIN CONTROLK955690AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3K946265FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3K935598PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2K946049LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2

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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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