510(k) K821583
K821583 is an FDA 510(k) premarket notification submitted by Gilford Instrument Laboratories, Inc. for the device "AMES/GILFORD OPTIMATE CLIN. CHEM & THER". The FDA issued a decision of Substantially Equivalent on June 24, 1982. The device falls under product code JJF (Analyzer, Chemistry, Micro, For Clinical Use), a Class I device regulated under 21 CFR 862.2170. Gilford Instrument Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 1982
- Date Received
- May 28, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Chemistry, Micro, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2170
- Review Panel
- CH
- Submission Type