PACKS-4 (TM) Analyzer

FDA 510(k) K912201 · Helena Laboratories

Substantially Equivalent

510(k) numberK912201

Submission

Device name
PACKS-4 (TM) Analyzer
Applicant
Helena Laboratories
Beaumont, TX, US
Received
May 20, 1991
Decision date
August 16, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JBY – Aggregometer, Platelet, Photo-Optical Scanning
Device class
Class II (moderate risk)
Regulation
21 CFR 864.6675
Specialty
Hematology

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Questions and answers

When was PACKS-4 (TM) Analyzer cleared by the FDA?

PACKS-4 (TM) Analyzer (K912201) received a 510(k) decision of Substantially Equivalent on August 16, 1991, 88 days after the submission was received.

What is the product code of K912201?

The FDA product code is JBY – Aggregometer, Platelet, Photo-Optical Scanning, a Class II (moderate risk) device regulated under 21 CFR 864.6675.