Ats Pva Fixative Solution
FDA 510(k) K881698 · Alpha-Tec Systems, Inc.
510(k) numberK881698
Submission
- Device name
- Ats Pva Fixative Solution
- Applicant
- Alpha-Tec Systems, Inc.
Irvine, CA, US - Received
- April 19, 1988
- Decision date
- May 13, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code LDZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883048 | Ats Para-Set Modified Pva Fixative SolutionLDZ · Traditional | Alpha-Tec Systems, Inc. | 08/17/1988SE |
| K881922 | Cytojars Prefilled with Cytology PreservativeLDZ · Traditional | Surgipath Medical Industries, Inc. | 05/25/1988SE |
| K862725 | Saccomanno Speciman SolutionLDZ · Traditional | Mill-Rose Laboratory | 08/01/1986SE |
| K843428 | BiofixLDZ · Traditional | Accra Laboratories, Inc. | 09/27/1984SE |
| K842913 | Wright Stain FixativeLDZ · Traditional | E K Ind., Inc. | 09/07/1984SE |
| K831061 | Pva Fixative/FormalinLDZ · Traditional | American Micro Scan | 06/08/1983SE |
| K761138 | Fa Tissue Fixative & Wash SetLDZ · Traditional | Zeus Scientific, Inc. | 01/06/1978SE |
More from Zeus Scientific, 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 Pva Fixative Solution cleared by the FDA?
Ats Pva Fixative Solution (K881698) received a 510(k) decision of Substantially Equivalent on May 13, 1988, 24 days after the submission was received.
What is the product code of K881698?
The FDA product code is LDZ – Fixative, Alcohol Containing, a Class I (low risk) device regulated under 21 CFR 864.4010.