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FDA 510(k)

Q.I.C. BLEEDING TIME DEVICE

K-Number: K871318 · 1987-06-10

ApplicantHelena Laboratories
Decision Date1987-06-10
Product CodeJCA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Q.I.C. BLEEDING TIME DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1987-06-10 under 510(k) number K871318. 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 Q.I.C. BLEEDING TIME DEVICE?

Q.I.C. BLEEDING TIME DEVICE is a medical device that received FDA 510(k) clearance on 1987-06-10. The listed applicant is Helena Laboratories. The 510(k) number is K871318.

When did Q.I.C. BLEEDING TIME DEVICE receive FDA 510(k) clearance?

Q.I.C. BLEEDING TIME DEVICE received FDA 510(k) clearance on 1987-06-10, under 510(k) number K871318.

Who is the listed applicant for Q.I.C. BLEEDING TIME DEVICE?

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

What is the FDA product code for Q.I.C. BLEEDING TIME DEVICE?

The FDA product code for Q.I.C. BLEEDING TIME DEVICE is JCA.

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Other records listing Helena Laboratories 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.

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

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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.K850542SURGICUTT - BLEEDING TIME DEVICEInternational Technidyne Corp.K830645BLEEDING TIME DEVICE DISPOSABLEAmerican DadeK801815AUTOLETUlster 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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