FDA Product Code
FDA Product Code JJC — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.2150
510(k) Clearances — 32 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K945915 | AVL OMNI ANALYZER | Avl Scientific Corp. | 1995-04-05 | Traditional | PDF ↗ |
| K945584 | NOVA 16 ANALYZER | Nova Biomedical Corp. | 1995-02-08 | Traditional | PDF ↗ |
| K943376 | OPERA SYSTEM | Miles, Inc. | 1994-09-14 | Traditional | PDF ↗ |
| K901410 | TECHNICON RA-2000(TM) SYSTEM | Technicon Instruments Corp. | 1990-07-17 | Traditional | PDF ↗ |
| K901141 | PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX | Baxter Healthcare Corp | 1990-04-09 | Traditional | PDF ↗ |
| K890332 | RFA/2 RAPID FLOW ANALYZER W/COMPUTER | Alpkem Corp. | 1989-02-17 | Traditional | PDF ↗ |
| K881056 | AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030 | American Research Products Co. | 1988-11-15 | Traditional | PDF ↗ |
| K875105 | TECHNICON SMAC 3 SYSTEM | Technicon Instruments Corp. | 1988-02-16 | Traditional | PDF ↗ |
| K870998 | TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS | Technicon Instruments Corp. | 1987-05-26 | Traditional | PDF ↗ |
| K862561 | TECHNICON RA-XT SYSTEM WITH ANALYTES | Technicon Instruments Corp. | 1986-10-20 | Traditional | PDF ↗ |
| K854345 | TECHNICON RA-500 SYSTEM | Technicon Instruments Corp. | 1985-11-26 | Traditional | PDF ↗ |
| K852306 | REPLACEMENT REAGENTS FOR SMAC II SYSTEMS | Methodist Hospital of Memphis | 1985-08-02 | Traditional | PDF ↗ |
| K833157 | LANCER ANALYZER CUPS | Sherwood Medical Co. | 1983-12-08 | Traditional | PDF ↗ |
| K833023 | TECHNICON RA-1000 SYSTEM | Technicon Instruments Corp. | 1983-11-03 | Traditional | PDF ↗ |
| K823233 | SBA 300 CLINICAL CHEMISTRY ANALYZER | Gilford Instrument Laboratories, Inc. | 1982-11-29 | Traditional | PDF ↗ |
| K813077 | TECHNICON RA 1000 SYSTEM | Technicon Corp. | 1981-11-16 | Traditional | PDF ↗ |
| K811249 | TECHNICON SMAC II SYSTEM & ACCESSORIES | Technicon Instruments Corp. | 1981-05-21 | Traditional | PDF ↗ |
| K810394 | PRE-VAP CAPS | Sherman Boosalis | 1981-03-06 | Traditional | PDF ↗ |
| K801481 | BMC RIAFLO SYSTEM | Boehringer Mannheim Corp. | 1980-08-20 | Traditional | PDF ↗ |
| K800587 | NSI WASH SOLUTION CONCENTRATE | Nobel Scientific Industries, Inc. | 1980-08-08 | Traditional | PDF ↗ |
| K800453 | PHOTOVOLT PVA 4M+2 ANALYZER | Photovolt Corp. | 1980-03-20 | Traditional | PDF ↗ |
| K792285 | TECHNICON C800 SYSTEM | Technicon Instruments Corp. | 1979-12-06 | Traditional | PDF ↗ |
| K781503 | TECHNICON STAT/LYTE ISE ELECTROLYTE | Technicon Instruments Corp. | 1978-09-27 | Traditional | PDF ↗ |
| K771662 | AUTOMATIC ANALYZER | Lachat Chemicals, Inc. | 1977-12-06 | Traditional | PDF ↗ |
| K771336 | SMA II | Technicon Instruments Corp. | 1977-08-26 | Traditional | PDF ↗ |
| K770506 | IN VITRO DIAGNOSTIC REAGENTS | Norwood Scientific Associates, Inc. | 1977-05-06 | Traditional | PDF ↗ |
| K761342 | SMA MICROLYZER | Technicon Instruments Corp. | 1977-02-01 | Traditional | PDF ↗ |
| K761086 | REAGENTS | Simmler & Son, Inc. | 1977-01-12 | Traditional | PDF ↗ |
| K760749 | SYSTEM 5 - SEMI-AUTOMATED CLIN. ANALY | Gilford Instrument Laboratories, Inc. | 1976-12-29 | Traditional | PDF ↗ |
| K761165 | MT II - TEST FOR CONTINUOUS FLOW ANAL | Technicon Instruments Corp. | 1976-12-13 | Traditional | PDF ↗ |
| K760622 | LANCER AUTOANALYZER MANIFOLD PUMP TUB | Sherwood Medical Industries | 1976-11-24 | Traditional | PDF ↗ |
| K760211 | ANALYZER, GLUCOSE/UREA/CREATININE | Instrumentation Laboratory CO | 1976-08-26 | Traditional | PDF ↗ |
Product code JJC · Class I · Clinical Chemistry. Data: openFDA.