Paracon Plus Formalin - Pcp-F, Paracon Plus Saf - Pcp-Saf and Paracon Plus MF - Pcp-Mf

FDA 510(k) K964144 · Para Scientific Co.

Substantially Equivalent

510(k) numberK964144

Submission

Device name
Paracon Plus Formalin - Pcp-F, Paracon Plus Saf - Pcp-Saf and Paracon Plus MF - Pcp-Mf
Applicant
Para Scientific Co.
Lake Oswego, OR, US
Received
October 17, 1996
Decision date
November 27, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LIO – Device, Specimen Collection
Device class
Class I (low risk)
Regulation
21 CFR 866.2900
Specialty
Microbiology

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Questions and answers

When was Paracon Plus Formalin - Pcp-F, Paracon Plus Saf - Pcp-Saf and Paracon Plus MF - Pcp-Mf cleared by the FDA?

Paracon Plus Formalin - Pcp-F, Paracon Plus Saf - Pcp-Saf and Paracon Plus MF - Pcp-Mf (K964144) received a 510(k) decision of Substantially Equivalent on November 27, 1996, 41 days after the submission was received.

What is the product code of K964144?

The FDA product code is LIO – Device, Specimen Collection, a Class I (low risk) device regulated under 21 CFR 866.2900.