510(k) K930366

16 X 25 MM TEST TUBE, CATALOG #01-461 by Proteins Intl., Inc. — Product Code KIR

K930366 is an FDA 510(k) premarket notification submitted by Proteins Intl., Inc. for the device "16 X 25 MM TEST TUBE, CATALOG #01-461". The FDA issued a decision of Substantially Equivalent on March 23, 1993. The device falls under product code KIR (Cells, Animal And Human, Cultured), a Class I device regulated under 21 CFR 864.2280. Proteins Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1993
Date Received
January 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cells, Animal And Human, Cultured
Device Class
Class I
Regulation Number
864.2280
Review Panel
PA
Submission Type