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FDA 510(k)

VIROTROL III

K-Number: K974613 · 1998-01-27

ApplicantBlackhawk Biosystems, Inc.
Decision Date1998-01-27
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VIROTROL III is the device name listed in this FDA 510(k) record. The listed applicant is Blackhawk Biosystems, Inc.. It received FDA 510(k) clearance on 1998-01-27 under 510(k) number K974613. 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 VIROTROL III?

VIROTROL III is a medical device that received FDA 510(k) clearance on 1998-01-27. The listed applicant is Blackhawk Biosystems, Inc.. The 510(k) number is K974613.

When did VIROTROL III receive FDA 510(k) clearance?

VIROTROL III received FDA 510(k) clearance on 1998-01-27, under 510(k) number K974613.

Who is the listed applicant for VIROTROL III?

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

What is the FDA product code for VIROTROL III?

The FDA product code for VIROTROL III 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 Blackhawk Biosystems, 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.

K972129CHLAMYDIATROL AGK954298VIROTROL IVK942295VIROTROL TORCH

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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