Saccomanno Speciman Solution
FDA 510(k) K862725 · Mill-Rose Laboratory
510(k) numberK862725
Submission
- Device name
- Saccomanno Speciman Solution
- Applicant
- Mill-Rose Laboratory
Mentor, OH, US - Received
- July 17, 1986
- Decision date
- August 1, 1986
- 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 |
| K881698 | Ats Pva Fixative SolutionLDZ · Traditional | Alpha-Tec Systems, Inc. | 05/13/1988SE |
| 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 |
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| K962736 | Mill-Rose Laryngoscopic Injection NeedleEOQ · Traditional | 07/29/1996SE |
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| K954519 | Wang Transendoscopic Aspiration NeedleFBK · Traditional | 12/22/1995SE |
| K951600 | Mill-Rose Rotatable Polypectomy SnareFDI · Traditional | 12/18/1995SE |
| K954745 | Mill-Rose Rigid Scope Cleaning BrushesFEB · Traditional | 11/27/1995SE |
| K951051 | Rite-Bite Biopsy ForcepsEOQ · Traditional | 03/24/1995SE |
| K951048 | Rite-Bite Biopsy ForcepsFCL · Traditional | 03/15/1995SE |
Questions and answers
When was Saccomanno Speciman Solution cleared by the FDA?
Saccomanno Speciman Solution (K862725) received a 510(k) decision of Substantially Equivalent on August 1, 1986, 15 days after the submission was received.
What is the product code of K862725?
The FDA product code is LDZ – Fixative, Alcohol Containing, a Class I (low risk) device regulated under 21 CFR 864.4010.