JQCClass I
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
21 CFR 862.2050 / Clinical Chemistry
JQC is the FDA product code for Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use, a class I device type, regulated under 21 CFR 862.2050. As of , FDA records hold 38 510(k) clearances under this code, the most recent dated , and 16 recalls.
Classification record
- Product code
- JQC
- Device name
- Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- Regulation
- 21 CFR 862.2050
- Device class
- Class I
- Review panel
- Clinical Chemistry
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 38
- Ingested recalls
- 16
Clearances, product code JQC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1979 | 1 |
| 1980 | 2 |
| 1981 | 3 |
| 1982 | 3 |
| 1983 | 3 |
| 1984 | 4 |
| 1985 | 1 |
| 1986 | 3 |
| 1987 | 1 |
| 1988 | 1 |
| 1994 | 1 |
| 1999 | 1 |
| 2000 | 1 |
| 2002 | 1 |
| 2003 | 3 |
| 2004 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 1 |
| 2010 | 1 |
| 2019 | 1 |
Applicants with the most clearances
Product code JQC| Applicant | Clearances |
|---|---|
| E.I. Dupont de Nemours & Co., Inc. | 3 |
| Terumo BCT, Ltd | 3 |
| Lkb Instruments, Inc. | 3 |
| Norfolk Scientific, Inc. | 3 |
| Biodynamics Corp. | 2 |
| Boehringer Mannheim Corp. | 2 |
| Damon Corp. | 2 |
| Perfusion Partners & Assoc., Inc. | 2 |
| Bel-Art Products | 1 |
| Biomet Manufacturing Corp | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Accumax Lab Devices Pvt Ltd
- Accuster Technologies Pvt. Ltd.
- Advanced Engineering, Inc.
- Advanced Molding Technologies
- Aesthetic experts labs Ltd
- Aikang MedTech Co., Ltd
- Andreas Hettich GmbH
- Anji Spenq Industrial Co., Ltd.
- Apex Biologix
- Apothecaries Sundries Mfg Pvt Ltd
- Arteriocyte Medical Systems, Inc.
- Arthrex Australia Pty Ltd.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
