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FDA 510(k)

URINE SCREENING KIT

K-Number: K830824 · 1983-06-12

ApplicantSyn-Kit, Inc.
Decision Date1983-06-12
Product CodeCEN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINE SCREENING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Syn-Kit, Inc.. It received FDA 510(k) clearance on 1983-06-12 under 510(k) number K830824. The device is classified under product code CEN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINE SCREENING KIT?

URINE SCREENING KIT is a medical device that received FDA 510(k) clearance on 1983-06-12. The listed applicant is Syn-Kit, Inc.. The 510(k) number is K830824.

When did URINE SCREENING KIT receive FDA 510(k) clearance?

URINE SCREENING KIT received FDA 510(k) clearance on 1983-06-12, under 510(k) number K830824.

Who is the listed applicant for URINE SCREENING KIT?

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

What is the FDA product code for URINE SCREENING KIT?

The FDA product code for URINE SCREENING KIT is CEN.

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Other records listing Syn-Kit, 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.

K861098SEROIDEN STREPTO KIT 'EIKEN'K861631SLIDE CULTURE U 'EIKEN'K854819CPR SLIDE EIKENK854820RA 80 EIKENK853276ASO SLIDE EIKENK843753UROPAPER EIKEN GP

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Related Devices (Code: CEN)

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.

K091287VS-SENSE TESTCommon Sense , Ltd.K071100AMNISCREEN HOME DETECTION LINER KITCommon Sense , Ltd.K051727AIMSTICK URINE REAGENT STRIPSGermaine Laboratories, Inc.K040008QUICKVUE ADVANCE PH AND AMINES GLL TESTQuidel Corp.K030650STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONSUridynamics, Inc.K962718FEMEXAM TESTCARDLitmus Concepts, 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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