Ats Trichrome Stain (Wheatley's Modification)
FDA 510(k) K881042 · Alpha-Tec Systems, Inc.
510(k) numberK881042
Submission
- Device name
- Ats Trichrome Stain (Wheatley's Modification)
- Applicant
- Alpha-Tec Systems, Inc.
Irvine, CA, US - Received
- March 11, 1988
- Decision date
- March 30, 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 |
| 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 |
|---|---|---|
| K053257 | Para-Pro FC50LKS · Traditional | 05/12/2006SE |
| K890861 | Ats Dobell & O'Connor's IodineJTS · Traditional | 03/23/1989SE |
| K890020 | Ats Lugol's Iodine SolutionJTS · Traditional | 02/24/1989SE |
| K890148 | Ats TB Rapid Stain Set Product #034-45ICL · Traditional | 01/24/1989SE |
| K890022 | Ats Mayer's AlbuminKEL · Traditional | 01/10/1989SE |
| K883049 | Ats Para-Set Iodine Alcohol SolutionJTS · Traditional | 08/17/1988SE |
| K883048 | Ats Para-Set Modified Pva Fixative SolutionLDZ · Traditional | 08/17/1988SE |
| K883062 | Ats Schaudinn's Fixative W/Acetic AcidLDW · Traditional | 08/04/1988SE |
| K881949 | Ats Nac-Pac SetJSK · Traditional | 05/25/1988SE |
| K881879 | Ats M/15 Phosphate Buffer, Product #034-42JSK · Traditional | 05/13/1988SE |
Questions and answers
When was Ats Trichrome Stain (Wheatley's Modification) cleared by the FDA?
Ats Trichrome Stain (Wheatley's Modification) (K881042) received a 510(k) decision of Substantially Equivalent on March 30, 1988, 19 days after the submission was received.
What is the product code of K881042?
The FDA product code is JTS – Stains, Microbiologic, a Class I (low risk) device regulated under 21 CFR 864.1850.