Buf-Fix
FDA 510(k) K842728 · E K Ind., Inc.
510(k) numberK842728
Submission
- Device name
- Buf-Fix
- Applicant
- E K Ind., Inc.
Mchenry, IL, US - Received
- July 13, 1984
- Decision date
- August 3, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IFP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884755 | Consed Fecal Concentration SystemIFP · Traditional | Donald L. Price, Ph.D. | 01/10/1989SE |
| K872663 | Dry-FormIFP · Traditional | Anatech, Ltd. | 08/06/1987SE |
| K872140 | (Msi) Path-SaverIFP · Traditional | Medical Specialties, Inc. | 06/15/1987SE |
| K870852 | NBF 10% Neutral Buffered FormalinIFP · Traditional | Anatech, Ltd. | 03/31/1987SE |
| K853497 | Prefilled Specimen Jars 10% Neutral Buf-FormalinIFP · Traditional | Surgipath Medical Industries, Inc. | 08/28/1985SE |
| K842982 | Formalin BufferedIFP · Traditional | Reagent Laboratory, Inc. | 10/01/1984SE |
| K842940 | Cba FormalinIFP · Traditional | Anatech, Ltd. | 08/28/1984SE |
| K840926 | Formalin Solution 10% Neutral BufferIFP · Traditional | Sigma Chemical Co. | 03/12/1984SE |
| K830583 | Neutral Buffered Formalin 10%IFP · Traditional | Surgipath Medical Industries, Inc. | 03/17/1983SE |
| K830582 | Millonig's Modified Phosphate BufferedIFP · Traditional | Surgipath Medical Industries, Inc. | 03/17/1983SE |
More from Surgipath Medical Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K842931 | Drabkin ReagentKAG · Traditional | 09/21/1984SE |
| K842938 | Acetic Acid 1% V/VGGK · Traditional | 09/14/1984SE |
| K842937 | Acetic Acid 2% V/VGGK · Traditional | 09/12/1984SE |
| K842936 | Acetic Acid, 3% V/VGGK · Traditional | 09/12/1984SE |
| K842935 | Acetic Acid, 5% V/VGGK · Traditional | 09/12/1984SE |
| K842934 | Decolorizing Fluic, Acid-Alcohol 3%PPM · Traditional | 09/12/1984SE |
| K842933 | Carbol-Fuchsin, Ziehl-NeedsenICL · Traditional | 09/11/1984SE |
| K842930 | Gomori's Trichrome StainLED · Traditional | 09/11/1984SE |
| K842928 | Jenner Blood StainKJX · Traditional | 09/11/1984SE |
| K842927 | Light Green SF 1%HYS · Traditional | 09/11/1984SE |
Questions and answers
When was Buf-Fix cleared by the FDA?
Buf-Fix (K842728) received a 510(k) decision of Substantially Equivalent on August 3, 1984, 21 days after the submission was received.
What is the product code of K842728?
The FDA product code is IFP – Formalin, Neutral Buffered, a Class I (low risk) device regulated under 21 CFR 864.4010.