Snap N' Stain Iodine Stain
FDA 510(k) K884069 · Scientific Device Laboratory, Inc.
510(k) numberK884069
Submission
- Device name
- Snap N' Stain Iodine Stain
- Applicant
- Scientific Device Laboratory, Inc.
Glenview, IL, US - Received
- September 27, 1988
- Decision date
- October 25, 1988
- 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 |
| K883052 | Metheno-Stain KitJTS · Traditional | Scientific Device Laboratory, Inc. | 08/30/1988SE |
| K883061 | Ats Para-Set Carbol-Xylene SolutionJTS · Traditional | Alpha-Tech Systems, Inc. | 08/17/1988SE |
More from Alpha-Tech Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K935316 | Parasafe(R) FixativeLKS · Traditional | 02/17/1994SE |
| K924893 | Microsporidium Control SlideLJG · Traditional | 01/15/1993SE |
| K911059 | Turbidometric StandardLIE · Traditional | 06/10/1991SE |
| K895848 | Pressure Steam SterilizersFLE · Traditional | 12/11/1989SE |
| K890718 | Gram Stain Control SlideLJG · Traditional | 03/16/1989SE |
| K890670 | Cryptosporidium Control SlideLJG · Traditional | 03/16/1989SE |
| K884011 | Snap N' Stain Iron StainGGH · Traditional | 10/06/1988SE |
| K883052 | Metheno-Stain KitJTS · Traditional | 08/30/1988SE |
| K881598 | SDL Trichrome StainJTS · Traditional | 05/04/1988SE |
| K840506 | Haemophilus Influenzae Type BLSC · Traditional | 04/04/1984SE |
Questions and answers
When was Snap N' Stain Iodine Stain cleared by the FDA?
Snap N' Stain Iodine Stain (K884069) received a 510(k) decision of Substantially Equivalent on October 25, 1988, 28 days after the submission was received.
What is the product code of K884069?
The FDA product code is JTS – Stains, Microbiologic, a Class I (low risk) device regulated under 21 CFR 864.1850.