Acid Fast Kit
FDA 510(k) K781643 · Bioscientific
510(k) numberK781643
Submission
- Device name
- Acid Fast Kit
- Applicant
- Bioscientific
Mchenry, IL, US - Received
- September 25, 1978
- Decision date
- October 3, 1978
- 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 |
|---|---|---|
| K812447 | Amylase Reagent KitKHM · Traditional | 09/09/1981SE |
| K811251 | Citrate BufferJCC · Traditional | 05/21/1981SE |
| K801268 | Hemoglobin Control LevelsKHG · Traditional | 07/14/1980SE |
| K801267 | Red Blood Cell Count & Hematocrit CNTLJPK · Traditional | 07/14/1980SE |
| K801265 | White Blood Cell Count Control LevelsJPK · Traditional | 07/14/1980SE |
| K791658 | Wright Stain Pack · Traditional | 10/17/1979SE |
| K791007 | Stat Diff StainKQC · Traditional | 08/03/1979SE |
| K790415 | HCP-7JPK · Traditional | 04/04/1979SE |
| K781734 | Sodium Chloride, 0.85% · Traditional | 10/24/1978SE |
| K781588 | Papanicolaou Stian OG-6HZJ · Traditional | 10/10/1978SE |
Questions and answers
When was Acid Fast Kit cleared by the FDA?
Acid Fast Kit (K781643) received a 510(k) decision of Substantially Equivalent on October 3, 1978, 8 days after the submission was received.
What is the product code of K781643?
The FDA product code is JTS – Stains, Microbiologic, a Class I (low risk) device regulated under 21 CFR 864.1850.