510(k) K843794
K843794 is an FDA 510(k) premarket notification submitted by Health Research, Inc. for the device "LATEX-R RICKETTSII". The FDA issued a decision of Substantially Equivalent on January 4, 1985. The device falls under product code GPP (Antiserum, Rocky Mountain Spotted Fever), a Class I device regulated under 21 CFR 866.3500. Health Research, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 1985
- Date Received
- September 27, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antiserum, Rocky Mountain Spotted Fever
- Device Class
- Class I
- Regulation Number
- 866.3500
- Review Panel
- MI
- Submission Type