Rapid NFT
FDA 510(k) K831186 · Dms Laboratories
510(k) numberK831186
Submission
- Device name
- Rapid NFT
- Applicant
- Dms Laboratories
Mchenry, IL, US - Received
- April 12, 1983
- Decision date
- May 9, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSN – Culture Media, Propagating Transport
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2390
- Specialty
- Microbiology
Other 510(k)s with product code JSN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000718 | ChromostreakJSN · Traditional | Novamed , Ltd. | 08/24/2000SE |
| K962745 | Enteric Pathogen Transport (Ept) (E1020,E1000)JSN · Traditional | Prepared Media Laboratory, Inc. | 10/02/1996SE |
| K961756 | Cytoquant Viral Transport MediumJSN · Traditional | Proteins Intl., Inc. | 05/17/1996SE |
| K961755 | Cytoquant Chlamydia Transport MediumJSN · Traditional | Proteins Intl., Inc. | 05/17/1996SE |
| K896296 | Inpouch-Tv PouchJSN · Traditional | Biomed Diagnostics, Inc. | 01/29/1990SE |
| K881579 | Amies Transport Medium W/O CharcoalJSN · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K860967 | Virtran Viral Transporter (Modified)JSN · Traditional | Diagnon Corp. | 04/04/1986SE |
| K841208 | Propagating TransportJSN · Traditional | Smith River Biologicals | 04/05/1984SE |
| K833968 | 10BJSN · Traditional | Remel Co. | 12/30/1983SE |
| K834065 | A3BJSN · Traditional | Remel Co. | 12/27/1983SE |
More from Remel Co.
| 510(k) | Device | Decision |
|---|---|---|
| K831187 | TRPJTO · Traditional | 05/09/1983SE |
| K830437 | CHSJSC · Traditional | 03/17/1983SE |
| K823102 | Agar PJSJ · Traditional | 12/03/1982SE |
| K821038 | Fast Violet BJTS · Traditional | 05/27/1982SE |
| K813613 | Rapid CHJTO · Traditional | 02/22/1982SE |
| K813612 | Rapid ZymeJTO · Traditional | 02/22/1982SE |
| K820213 | Saline SolutionJTO · Traditional | 02/12/1982SE |
| K820212 | OxiJTO · Traditional | 02/12/1982SE |
| K820211 | NinhydrinJTO · Traditional | 02/12/1982SE |
| K820210 | IndJTO · Traditional | 02/12/1982SE |
Questions and answers
When was Rapid NFT cleared by the FDA?
Rapid NFT (K831186) received a 510(k) decision of Substantially Equivalent on May 9, 1983, 27 days after the submission was received.
What is the product code of K831186?
The FDA product code is JSN – Culture Media, Propagating Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.