Fast Violet B
FDA 510(k) K821038 · Dms Laboratories
510(k) numberK821038
Submission
- Device name
- Fast Violet B
- Applicant
- Dms Laboratories
Mchenry, IL, US - Received
- April 13, 1982
- Decision date
- May 27, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTS – Stains, Microbiologic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code JTS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960095 | Bactidrop Calcofluor WhiteJTS · Traditional | Remel Co. | 03/19/1996SE |
| K960090 | Calcofluor White Stain KitJTS · Traditional | Remel Co. | 03/19/1996SE |
| K920976 | Bactidrop India InkJTS · Traditional | Remel Co. | 06/09/1992SE |
| K920975 | Bactidrop Calcofluor WhiteJTS · Traditional | Remel Co. | 06/09/1992SE |
| K920970 | Bactidrop Koh (10%)JTS · Traditional | Remel Co. | 06/09/1992SE |
| K893530 | Iristain Formula 2, Parts 1 and 2JTS · Traditional | Intl. Remote Imaging Systems | 06/13/1989SE |
| K890861 | Ats Dobell & O'Connor's IodineJTS · Traditional | Alpha-Tec Systems, Inc. | 03/23/1989SE |
| K890020 | Ats Lugol's Iodine SolutionJTS · Traditional | Alpha-Tec Systems, Inc. | 02/24/1989SE |
| K884069 | Snap N' Stain Iodine StainJTS · Traditional | Scientific Device Laboratory, Inc. | 10/25/1988SE |
| K883052 | Metheno-Stain KitJTS · Traditional | Scientific Device Laboratory, Inc. | 08/30/1988SE |
More from Scientific Device Laboratory, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K831187 | TRPJTO · Traditional | 05/09/1983SE |
| K831186 | Rapid NFTJSN · Traditional | 05/09/1983SE |
| K830437 | CHSJSC · Traditional | 03/17/1983SE |
| K823102 | Agar PJSJ · Traditional | 12/03/1982SE |
| 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 Fast Violet B cleared by the FDA?
Fast Violet B (K821038) received a 510(k) decision of Substantially Equivalent on May 27, 1982, 44 days after the submission was received.
What is the product code of K821038?
The FDA product code is JTS – Stains, Microbiologic, a Class I (low risk) device regulated under 21 CFR 864.1850.