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FDA 510(k)

SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS

K-Number: K971210 · 1997-04-17

ApplicantBeckman Instruments, Inc.
Decision Date1997-04-17
Product CodeLAS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1997-04-17 under 510(k) number K971210. The device is classified under product code LAS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS?

SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS is a medical device that received FDA 510(k) clearance on 1997-04-17. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K971210.

When did SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS receive FDA 510(k) clearance?

SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS received FDA 510(k) clearance on 1997-04-17, under 510(k) number K971210.

Who is the listed applicant for SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS?

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

What is the FDA product code for SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS?

The FDA product code for SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS is LAS.

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Other records listing Beckman Instruments, 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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERK981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

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Related Devices (Code: LAS)

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.

K080459CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLSChromsystems Instruments & Chemicals GmbHK072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELMore DiagnosticsK062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLQuantimetrix Corp.K051074MAS IMMUNOSUPPRESSANT CONTROLSMicrogenics Corp.K040411DRI OXYCODONE ASSAYMicrogenics Corp.K032842MICROGENICS CYCLOSPORINE CONTROL KITMicrogenics Corp.

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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