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FDA 510(k)

HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3

K-Number: K935599 · 1994-10-31

ApplicantClinical Controls, Inc.
Decision Date1994-10-31
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 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 1994-10-31 under 510(k) number K935599. 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 HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3?

HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3 is a medical device that received FDA 510(k) clearance on 1994-10-31. The listed applicant is Clinical Controls, Inc.. The 510(k) number is K935599.

When did HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3 receive FDA 510(k) clearance?

HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3 received FDA 510(k) clearance on 1994-10-31, under 510(k) number K935599.

Who is the listed applicant for HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 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 HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3?

The FDA product code for HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3 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 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: 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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