Cytojars Prefilled with Cytology Preservative
FDA 510(k) K881922 · Surgipath Medical Industries, Inc.
510(k) numberK881922
Submission
- Device name
- Cytojars Prefilled with Cytology Preservative
- Applicant
- Surgipath Medical Industries, Inc.
Grayslake, IL, US - Received
- May 9, 1988
- Decision date
- May 25, 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 |
| K881698 | Ats Pva Fixative SolutionLDZ · Traditional | Alpha-Tec Systems, Inc. | 05/13/1988SE |
| 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 |
|---|---|---|
| K883217 | Schiff ReagentHZT · Traditional | 08/05/1988SE |
| K881921 | C-E BrushHHT · Traditional | 07/19/1988SE |
| K881659 | Tissue Section AdhesiveIFZ · Traditional | 04/21/1988SE |
| K863549 | Reusable/Disposable Autopsy Knife SetEMF · Traditional | 09/30/1986SE |
| K863616 | Knife MakerIDL · Traditional | 09/25/1986SE |
| K863548 | Rotary MicrotomeIDO · Traditional | 09/19/1986SE |
| K863483 | Cassette EmbosseerIDZ · Traditional | 09/16/1986SE |
| K863145 | Cervical ScrapersHHT · Traditional | 08/19/1986SE |
| K861270 | Blue Ribbon Paraffin Infiltration/Embedding Med.KEO · Traditional | 04/11/1986SE |
| K861201 | Formaldehyde Solution, 37%IGG · Traditional | 04/11/1986SE |
Questions and answers
When was Cytojars Prefilled with Cytology Preservative cleared by the FDA?
Cytojars Prefilled with Cytology Preservative (K881922) received a 510(k) decision of Substantially Equivalent on May 25, 1988, 16 days after the submission was received.
What is the product code of K881922?
The FDA product code is LDZ – Fixative, Alcohol Containing, a Class I (low risk) device regulated under 21 CFR 864.4010.