510(k) K811793

FIX-RIGHT 90ML & 180 ML PREFILLED CONT by Richard-Allan Medical Ind., Inc. — Product Code KDT

K811793 is an FDA 510(k) premarket notification submitted by Richard-Allan Medical Ind., Inc. for the device "FIX-RIGHT 90ML & 180 ML PREFILLED CONT". The FDA issued a decision of Substantially Equivalent on July 31, 1981. The device falls under product code KDT (Container, Specimen Mailer And Storage, Sterile), a Class I device regulated under 21 CFR 864.3250. Richard-Allan Medical Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1981
Date Received
June 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Specimen Mailer And Storage, Sterile
Device Class
Class I
Regulation Number
864.3250
Review Panel
PA
Submission Type