JJC — Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use Class I
FDA product code JJC covers "Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use", a Class I medical device regulated under 21 CFR 862.2150. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JJC
- Device Class
- Class I
- Regulation Number
- 862.2150
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K945915 | avl scientific | AVL OMNI ANALYZER | April 5, 1995 |
| K945584 | nova biomedical | NOVA 16 ANALYZER | February 8, 1995 |
| K943376 | miles | OPERA SYSTEM | September 14, 1994 |
| K901410 | technicon instruments | TECHNICON RA-2000(TM) SYSTEM | July 17, 1990 |
| K901141 | baxter healthcare | PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX | April 9, 1990 |
| K890332 | alpkem | RFA/2 RAPID FLOW ANALYZER W/COMPUTER | February 17, 1989 |
| K881056 | american research products | AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030 | November 15, 1988 |
| K875105 | technicon instruments | TECHNICON SMAC 3 SYSTEM | February 16, 1988 |
| K870998 | technicon instruments | TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS | May 26, 1987 |
| K862561 | technicon instruments | TECHNICON RA-XT SYSTEM WITH ANALYTES | October 20, 1986 |
| K854345 | technicon instruments | TECHNICON RA-500 SYSTEM | November 26, 1985 |
| K852306 | methodist hospital of memphis | REPLACEMENT REAGENTS FOR SMAC II SYSTEMS | August 2, 1985 |
| K833157 | sherwood medical | LANCER ANALYZER CUPS | December 8, 1983 |
| K833023 | technicon instruments | TECHNICON RA-1000 SYSTEM | November 3, 1983 |
| K823233 | gilford instrument laboratories | SBA 300 CLINICAL CHEMISTRY ANALYZER | November 29, 1982 |
| K813077 | technicon | TECHNICON RA 1000 SYSTEM | November 16, 1981 |
| K811249 | technicon instruments | TECHNICON SMAC II SYSTEM & ACCESSORIES | May 21, 1981 |
| K810394 | sherman boosalis | PRE-VAP CAPS | March 6, 1981 |
| K801481 | boehringer mannheim | BMC RIAFLO SYSTEM | August 20, 1980 |
| K800587 | nobel scientific industries | NSI WASH SOLUTION CONCENTRATE | August 8, 1980 |