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FDA 510(k)

VIROTROL TORCH

K-Number: K942295 · 1994-10-07

ApplicantBlackhawk Biosystems, Inc.
Decision Date1994-10-07
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VIROTROL TORCH 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 1994-10-07 under 510(k) number K942295. 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 TORCH?

VIROTROL TORCH is a medical device that received FDA 510(k) clearance on 1994-10-07. The listed applicant is Blackhawk Biosystems, Inc.. The 510(k) number is K942295.

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

VIROTROL TORCH received FDA 510(k) clearance on 1994-10-07, under 510(k) number K942295.

Who is the listed applicant for VIROTROL TORCH?

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 TORCH?

The FDA product code for VIROTROL TORCH 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.

K974613VIROTROL IIIK972129CHLAMYDIATROL AGK954298VIROTROL IV

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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