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FDA 510(k)

FERRITIN CONTROL - LEVEL 1, 2, 3

K-Number: K946266 · 1995-02-10

ApplicantClinical Controls, Inc.
Decision Date1995-02-10
Product CodeDGD
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FERRITIN CONTROL - LEVEL 1, 2, 3 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 1995-02-10 under 510(k) number K946266. The device is classified under product code DGD. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FERRITIN CONTROL - LEVEL 1, 2, 3?

FERRITIN CONTROL - LEVEL 1, 2, 3 is a medical device that received FDA 510(k) clearance on 1995-02-10. The listed applicant is Clinical Controls, Inc.. The 510(k) number is K946266.

When did FERRITIN CONTROL - LEVEL 1, 2, 3 receive FDA 510(k) clearance?

FERRITIN CONTROL - LEVEL 1, 2, 3 received FDA 510(k) clearance on 1995-02-10, under 510(k) number K946266.

Who is the listed applicant for FERRITIN CONTROL - LEVEL 1, 2, 3?

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 FERRITIN CONTROL - LEVEL 1, 2, 3?

The FDA product code for FERRITIN CONTROL - LEVEL 1, 2, 3 is DGD.

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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 CONTROLK955691SERUM VOLATILES CONTROL LEVEL 1 & 2K955690AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3K946265FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3K935598PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2

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Related Devices (Code: DGD)

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.

K881345IMX FERRITINAbbott LaboratoriesK830229ROENTGENOGRAPHY SETMallinckrodt Critical Care

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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