510(k) K062565
- Device
- STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE
- Applicant
- PRINCETON BIOMEDITECH CORP.
- 510(k) number
- K062565
- Product code
- MKU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-02-20
- Date received
- 2006-08-31
- Regulation
- 862.3220
- Classification name
- Enzyme Immunoassay, Nicotine And Nicotine Metabolites
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KYUNG-AH KIM
- Address
- 4242 U.S. Rt. 1 Monmouth Junction NJ US 08852 08852
FDA Registration Numbers#
- 3010939897
- 3003610499
- 3005174594
- 3011522054
- 3008517993
- 3003917514
- 2246703
- 2030633
- 3003760091
- 3010934853
- 3009238284
Source Documents#
Other 510(k) Records For Product Code MKU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192517 | Psychemedics Microplate EIA for Cotinine in Hair | Psychemedics Corporation | 2020-04-22 |
| K192299 | LZI Cotinine II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2019-11-21 |
| K021944 | COZART EIA COTININE URINE KIT | Cozart Bioscience , Ltd. | 2003-05-14 |
| K974534 | MICRO-PLATE COTININE EIA | OraSure Technologies, Inc. | 1998-05-18 |
| K974234 | MICRO-PLATE COTININE EIA | OraSure Technologies, Inc. | 1998-05-14 |
| K972481 | AUTO-LYTE COTININE EIA | OraSure Technologies, Inc. | 1997-10-21 |
Legacy Summary#
summary
FDA Review#
Decision Summary