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FDA 510(k)

TRACE ELEMENTS SERUM TOXICOLOGY CONTROL

K-Number: K883147 · 1988-10-06

ApplicantUtak Laboratories, Inc.
Decision Date1988-10-06
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRACE ELEMENTS SERUM TOXICOLOGY CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Utak Laboratories, Inc.. It received FDA 510(k) clearance on 1988-10-06 under 510(k) number K883147. 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 TRACE ELEMENTS SERUM TOXICOLOGY CONTROL?

TRACE ELEMENTS SERUM TOXICOLOGY CONTROL is a medical device that received FDA 510(k) clearance on 1988-10-06. The listed applicant is Utak Laboratories, Inc.. The 510(k) number is K883147.

When did TRACE ELEMENTS SERUM TOXICOLOGY CONTROL receive FDA 510(k) clearance?

TRACE ELEMENTS SERUM TOXICOLOGY CONTROL received FDA 510(k) clearance on 1988-10-06, under 510(k) number K883147.

Who is the listed applicant for TRACE ELEMENTS SERUM TOXICOLOGY CONTROL?

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

What is the FDA product code for TRACE ELEMENTS SERUM TOXICOLOGY CONTROL?

The FDA product code for TRACE ELEMENTS SERUM TOXICOLOGY CONTROL is JJY.

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Other records listing Utak Laboratories, 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.

K903061UTAK LABORATORIES TOXICOLOGY CONTROLK862419SERUM VANCOMYCIN TOXICOLOGY CONTROLK862418BENZODIAZEPINES TOXICOLOGY CONTROLK862421SERUM CLONAZEPAM TOXICOLOGY CONTROLK862420UTAK-STABBS TOXICOLOGY CONTROLK831736TRICYCLIC ANTIDEPRESSANTS

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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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