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FDA 510(k)

QUALITROL IGAME CONTROLS, LEVELS 1 AND 2

K-Number: K961544 · 1996-09-24

ApplicantConsolidated Technologies, Inc.
Decision Date1996-09-24
Product CodeDGR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 is the device name listed in this FDA 510(k) record. The listed applicant is Consolidated Technologies, Inc.. It received FDA 510(k) clearance on 1996-09-24 under 510(k) number K961544. The device is classified under product code DGR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUALITROL IGAME CONTROLS, LEVELS 1 AND 2?

QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 is a medical device that received FDA 510(k) clearance on 1996-09-24. The listed applicant is Consolidated Technologies, Inc.. The 510(k) number is K961544.

When did QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 receive FDA 510(k) clearance?

QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 received FDA 510(k) clearance on 1996-09-24, under 510(k) number K961544.

Who is the listed applicant for QUALITROL IGAME CONTROLS, LEVELS 1 AND 2?

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

What is the FDA product code for QUALITROL IGAME CONTROLS, LEVELS 1 AND 2?

The FDA product code for QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 is DGR.

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Other records listing Consolidated Technologies, 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.

K000116QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3K992576URINE CHEMISTRY CONTROL, LEVEL 1K992578URINE CHEMISTRY CONTROL, LEVEL 2K992151REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINEK981339QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3K974699REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE

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Related Devices (Code: DGR)

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.

K902220PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROLBoehringer Mannheim Corp.K865014LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & IIBio-RadK790298RADIOASSAY, CONTROL SERUM I, II, IIIKallestad Laboratories, Inc.K781355ICS NORMAL CONTROL SERUMBeckman Instruments, Inc.

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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