510(k) K812370
K812370 is an FDA 510(k) premarket notification submitted by Dutchland Laboratories, Inc. for the device "GUINEA PIG COMPLEMENT REGULAR". The FDA issued a decision of Substantially Equivalent on September 8, 1981. The device falls under product code KTQ (Reagent, Complement), a Class I device regulated under 21 CFR 866.4100. Dutchland Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 1981
- Date Received
- August 20, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagent, Complement
- Device Class
- Class I
- Regulation Number
- 866.4100
- Review Panel
- IM
- Submission Type