FDA 510(k)

WESTERGREN DISPETTE FOR ESR

K-Number: K831195 · 1983-05-09

Decision Date1983-05-09

Product CodeJPH

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

WESTERGREN DISPETTE FOR ESR is the device name listed in this FDA 510(k) record. The listed applicant is Ulster Scientific, Inc.. It received FDA 510(k) clearance on 1983-05-09 under 510(k) number K831195. The device is classified under product code JPH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WESTERGREN DISPETTE FOR ESR?

WESTERGREN DISPETTE FOR ESR is a medical device that received FDA 510(k) clearance on 1983-05-09. The listed applicant is Ulster Scientific, Inc.. The 510(k) number is K831195.

When did WESTERGREN DISPETTE FOR ESR receive FDA 510(k) clearance?

WESTERGREN DISPETTE FOR ESR received FDA 510(k) clearance on 1983-05-09, under 510(k) number K831195.

Who is the listed applicant for WESTERGREN DISPETTE FOR ESR?

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

What is the FDA product code for WESTERGREN DISPETTE FOR ESR?

The FDA product code for WESTERGREN DISPETTE FOR ESR is JPH.

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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.