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FDA 510(k)

BLEEDING TIME DEVICE DISPOSABLE

K-Number: K830645 · 1983-03-17

ApplicantAmerican Dade
Decision Date1983-03-17
Product CodeJCA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BLEEDING TIME DEVICE DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1983-03-17 under 510(k) number K830645. The device is classified under product code JCA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLEEDING TIME DEVICE DISPOSABLE?

BLEEDING TIME DEVICE DISPOSABLE is a medical device that received FDA 510(k) clearance on 1983-03-17. The listed applicant is American Dade. The 510(k) number is K830645.

When did BLEEDING TIME DEVICE DISPOSABLE receive FDA 510(k) clearance?

BLEEDING TIME DEVICE DISPOSABLE received FDA 510(k) clearance on 1983-03-17, under 510(k) number K830645.

Who is the listed applicant for BLEEDING TIME DEVICE DISPOSABLE?

The FDA 510(k) record lists American Dade as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLEEDING TIME DEVICE DISPOSABLE?

The FDA product code for BLEEDING TIME DEVICE DISPOSABLE is JCA.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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Related Devices (Code: JCA)

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.

K911745SIMPLATE PEDIATRICOrganon Teknika Corp.K911996SURGICUTT-BLEEDING TIME DEVICE, MODIFICATIONInternational Technidyne Corp.K871318Q.I.C. BLEEDING TIME DEVICEHelena LaboratoriesK850542SURGICUTT - BLEEDING TIME DEVICEInternational Technidyne Corp.K801815AUTOLETUlster Scientific, Inc.K761250SIMPLATEGeneral Diagnostics

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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