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FDA 510(k)

QUALITROL ANA CONTROL SERUM SET

K-Number: K961815 · 1996-09-27

ApplicantConsolidated Technologies, Inc.
Decision Date1996-09-27
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUALITROL ANA CONTROL SERUM SET 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 1996-09-27 under 510(k) number K961815. The device is classified under product code LKJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUALITROL ANA CONTROL SERUM SET?

QUALITROL ANA CONTROL SERUM SET is a medical device that received FDA 510(k) clearance on 1996-09-27. The listed applicant is Consolidated Technologies, Inc.. The 510(k) number is K961815.

When did QUALITROL ANA CONTROL SERUM SET receive FDA 510(k) clearance?

QUALITROL ANA CONTROL SERUM SET received FDA 510(k) clearance on 1996-09-27, under 510(k) number K961815.

Who is the listed applicant for QUALITROL ANA CONTROL SERUM SET?

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 ANA CONTROL SERUM SET?

The FDA product code for QUALITROL ANA CONTROL SERUM SET is LKJ.

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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: LKJ)

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.

K210902EliA Ro52, EliA Ro60Phadia ABK113610ANA-SCREEN WITH MDSSBio-Rad LaboratoriesK082759ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAYPhadia US, Inc.K081104AESKULISA ANA HEP-2, REF 30-7115USAesku DiagnosticsK041658BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200Bio-Rad Laboratories, Inc.K042416ATHENA MULTI-LYTE ANA-II TEST SYSTEMZeus Scientific, 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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