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FDA 510(k)

SHAPE-ACTIO METAL TOXICOLOGY CONTROL

K-Number: K863915 · 1986-11-24

ApplicantShape Products Co.
Decision Date1986-11-24
Product CodeDIE
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SHAPE-ACTIO METAL TOXICOLOGY CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Shape Products Co.. It received FDA 510(k) clearance on 1986-11-24 under 510(k) number K863915. The device is classified under product code DIE. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHAPE-ACTIO METAL TOXICOLOGY CONTROL?

SHAPE-ACTIO METAL TOXICOLOGY CONTROL is a medical device that received FDA 510(k) clearance on 1986-11-24. The listed applicant is Shape Products Co.. The 510(k) number is K863915.

When did SHAPE-ACTIO METAL TOXICOLOGY CONTROL receive FDA 510(k) clearance?

SHAPE-ACTIO METAL TOXICOLOGY CONTROL received FDA 510(k) clearance on 1986-11-24, under 510(k) number K863915.

Who is the listed applicant for SHAPE-ACTIO METAL TOXICOLOGY CONTROL?

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

What is the FDA product code for SHAPE-ACTIO METAL TOXICOLOGY CONTROL?

The FDA product code for SHAPE-ACTIO METAL TOXICOLOGY CONTROL is DIE.

Related Clinical Trials

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Related Devices (Code: DIE)

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.

K020610LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529Bio-RadK990928LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405Bio-RadK891691LYPHOCHEK URINE METALS CONTROL, LEVELS I AND IIBio-RadK890721SHAPE-ACTIO METAL TOXICOLOGY CONTROLActio, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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