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FDA 510(k)

SHAPE-ACTIO URINALYSIS CONTROLS

K-Number: K890442 · 1989-03-08

ApplicantActio, Inc.
Decision Date1989-03-08
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SHAPE-ACTIO URINALYSIS CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Actio, Inc.. It received FDA 510(k) clearance on 1989-03-08 under 510(k) number K890442. 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 SHAPE-ACTIO URINALYSIS CONTROLS?

SHAPE-ACTIO URINALYSIS CONTROLS is a medical device that received FDA 510(k) clearance on 1989-03-08. The listed applicant is Actio, Inc.. The 510(k) number is K890442.

When did SHAPE-ACTIO URINALYSIS CONTROLS receive FDA 510(k) clearance?

SHAPE-ACTIO URINALYSIS CONTROLS received FDA 510(k) clearance on 1989-03-08, under 510(k) number K890442.

Who is the listed applicant for SHAPE-ACTIO URINALYSIS CONTROLS?

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

What is the FDA product code for SHAPE-ACTIO URINALYSIS CONTROLS?

The FDA product code for SHAPE-ACTIO URINALYSIS CONTROLS is JJY.

Related Clinical Trials

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.

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Other records listing Actio, 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.

K902699SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY)K885282ASSAYED CHOLINESTERASE CONTROLK890721SHAPE-ACTIO METAL TOXICOLOGY CONTROL

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

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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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