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FDA 510(k)

I-STAT COAGULATION CONTROL SET

K-Number: K981752 · 1998-06-15

ApplicantBiopool Intl., Inc.
Decision Date1998-06-15
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

I-STAT COAGULATION CONTROL SET 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 1998-06-15 under 510(k) number K981752. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-STAT COAGULATION CONTROL SET?

I-STAT COAGULATION CONTROL SET is a medical device that received FDA 510(k) clearance on 1998-06-15. The listed applicant is Biopool Intl., Inc.. The 510(k) number is K981752.

When did I-STAT COAGULATION CONTROL SET receive FDA 510(k) clearance?

I-STAT COAGULATION CONTROL SET received FDA 510(k) clearance on 1998-06-15, under 510(k) number K981752.

Who is the listed applicant for I-STAT COAGULATION CONTROL SET?

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 I-STAT COAGULATION CONTROL SET?

The FDA product code for I-STAT COAGULATION CONTROL SET is GGN.

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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 1447K983898BIOCLOT APC SENSITIVITYK980314FETAL D TECTION KIT

Related Devices (Code: GGN)

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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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