510(k) K813513
K813513 is an FDA 510(k) premarket notification submitted by Dutchland Laboratories, Inc. for the device "AFRICAN GREEN MONKEY BLOOD IN ALSERVERS". The FDA issued a decision of Substantially Equivalent on December 31, 1981. The device falls under product code LHW (Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment), a Class I device regulated under 21 CFR 866.3720. Dutchland Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 31, 1981
- Date Received
- December 15, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment
- Device Class
- Class I
- Regulation Number
- 866.3720
- Review Panel
- MI
- Submission Type