Tomtec Gram Stainer Crystal Violet
FDA 510(k) K871532 · Remel Co.
510(k) numberK871532
Submission
- Device name
- Tomtec Gram Stainer Crystal Violet
- Applicant
- Remel Co.
Lenexa, KS, US - Received
- April 20, 1987
- Decision date
- April 29, 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
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| 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 |
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Questions and answers
When was Tomtec Gram Stainer Crystal Violet cleared by the FDA?
Tomtec Gram Stainer Crystal Violet (K871532) received a 510(k) decision of Substantially Equivalent on April 29, 1987, 9 days after the submission was received.
What is the product code of K871532?
The FDA product code is JTS – Stains, Microbiologic, a Class I (low risk) device regulated under 21 CFR 864.1850.