510(k) K802128
K802128 is an FDA 510(k) premarket notification submitted by Nolan Biological Laboratories, Inc. for the device "IMMUNODIFFUSSION REAGENTS/SEROLOGICAL". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code JWW (Antigen, Cf, B. Dermatitidis), a Class II device regulated under 21 CFR 866.3060. Nolan Biological Laboratories, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 1980
- Date Received
- August 4, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Cf, B. Dermatitidis
- Device Class
- Class II
- Regulation Number
- 866.3060
- Review Panel
- MI
- Submission Type