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FDA 510(k)

BIOCLOT APC SENSITIVITY

K-Number: K983898 · 1999-01-06

ApplicantBiopool Intl., Inc.
Decision Date1999-01-06
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BIOCLOT APC SENSITIVITY is the device name listed in this FDA 510(k) record. The listed applicant is Biopool Intl., Inc.. It received FDA 510(k) clearance on 1999-01-06 under 510(k) number K983898. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCLOT APC SENSITIVITY?

BIOCLOT APC SENSITIVITY is a medical device that received FDA 510(k) clearance on 1999-01-06. The listed applicant is Biopool Intl., Inc.. The 510(k) number is K983898.

When did BIOCLOT APC SENSITIVITY receive FDA 510(k) clearance?

BIOCLOT APC SENSITIVITY received FDA 510(k) clearance on 1999-01-06, under 510(k) number K983898.

Who is the listed applicant for BIOCLOT APC SENSITIVITY?

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

What is the FDA product code for BIOCLOT APC SENSITIVITY?

The FDA product code for BIOCLOT APC SENSITIVITY is GGP.

Related Clinical Trials

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Other records listing Biopool Intl., 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.

K002642MINIQUANT D-DIMER, MODEL 1447K981752I-STAT COAGULATION CONTROL SETK980314FETAL D TECTION KIT

Related Devices (Code: GGP)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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