Myco-Fluor Reagent a & B
FDA 510(k) K874662 · Scott Laboratories, Inc.
510(k) numberK874662
Submission
- Device name
- Myco-Fluor Reagent a & B
- Applicant
- Scott Laboratories, Inc.
Sulphur, LA, US - Received
- November 13, 1987
- Decision date
- November 25, 1987
- 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 |
|---|---|---|
| K880694 | B. Cat ConfirmJTO · Traditional | 06/16/1988SE |
| K874933 | Mug-Indole DiscJTO · Traditional | 01/05/1988SE |
| K873509 | Identicult-BlJTO · Traditional | 10/15/1987SE |
| K871238 | AnabagKZJ · Traditional | 04/03/1987SE |
| K863025 | Sero-Stat R II Staphylococcus TestLHT · Traditional | 09/15/1986SE |
| K852869 | Selecticult-ChlamydiaLKH · Traditional | 09/19/1985SE |
| K852832 | Identicult-NeisseriaJTO · Traditional | 07/19/1985SE |
| K852666 | Identicult-AeJTO · Traditional | 07/15/1985SE |
| K841680 | Scott Selecticult-Hsv Isolation &GQL · Traditional | 10/30/1984SE |
| K811098 | Sero-Stat Staphylococcus TestJWX · Traditional | 05/05/1981SE |
Questions and answers
When was Myco-Fluor Reagent a & B cleared by the FDA?
Myco-Fluor Reagent a & B (K874662) received a 510(k) decision of Substantially Equivalent on November 25, 1987, 12 days after the submission was received.
What is the product code of K874662?
The FDA product code is JTS – Stains, Microbiologic, a Class I (low risk) device regulated under 21 CFR 864.1850.