FDA 510(k)

PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560

K-Number: K010750 · 2001-09-07

Decision Date2001-09-07

Product CodeGGN

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Diagnostics. It received FDA 510(k) clearance on 2001-09-07 under 510(k) number K010750. 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 PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560?

PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 is a medical device that received FDA 510(k) clearance on 2001-09-07. The listed applicant is Fisher Diagnostics. The 510(k) number is K010750.

When did PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 receive FDA 510(k) clearance?

PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 received FDA 510(k) clearance on 2001-09-07, under 510(k) number K010750.

Who is the listed applicant for PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560?

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

What is the FDA product code for PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560?

The FDA product code for PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 is 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.