Biofix
FDA 510(k) K843428 · Accra Laboratories, Inc.
510(k) numberK843428
Submission
- Device name
- Biofix
- Applicant
- Accra Laboratories, Inc.
Mchenry, IL, US - Received
- September 4, 1984
- Decision date
- September 27, 1984
- 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 |
| K862725 | Saccomanno Speciman SolutionLDZ · Traditional | Mill-Rose Laboratory | 08/01/1986SE |
| 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 |
|---|---|---|
| K851494 | Two-Step Acid Fast Bacteria StainJTS · Traditional | 04/29/1985SE |
| K851493 | Kinyoun Acid Fast Stain KitJTS · Traditional | 04/29/1985SE |
| K843427 | Gill Papanicolaou Stain EA-1 & 2 OG-6HZJ · Traditional | 10/02/1984SE |
| K843425 | Harris Hematoxylin, Mercury Free, AcidHYK · Traditional | 10/02/1984SE |
| K843426 | Eosin Y 1% AlcoholicHYB · Traditional | 09/27/1984SE |
| K843429 | Gram Stain Set W/Stabilized IodineJTS · Traditional | 09/14/1984SE |
| K831090 | Hematoxylin Gill Formulation IX#56016HYJ · Traditional | 06/08/1983SE |
| K830542 | Hemaquik II Staining Solution #55961IAF · Traditional | 03/17/1983SE |
| K823329 | Papincolabu Stain EA-36/50/65 & OG-6HZL · Traditional | 12/28/1982SE |
| K823328 | Harris HematoxylinHYK · Traditional | 12/28/1982SE |
Questions and answers
When was Biofix cleared by the FDA?
Biofix (K843428) received a 510(k) decision of Substantially Equivalent on September 27, 1984, 23 days after the submission was received.
What is the product code of K843428?
The FDA product code is LDZ – Fixative, Alcohol Containing, a Class I (low risk) device regulated under 21 CFR 864.4010.