NBF 10% Neutral Buffered Formalin
FDA 510(k) K870852 · Anatech, Ltd.
510(k) numberK870852
Submission
- Device name
- NBF 10% Neutral Buffered Formalin
- Applicant
- Anatech, Ltd.
Battle Creek, MI, US - Received
- March 3, 1987
- Decision date
- March 31, 1987
- 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 |
| 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 |
| K842728 | Buf-FixIFP · Traditional | E K Ind., Inc. | 08/03/1984SE |
| 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 |
|---|---|---|
| K882874 | Zinc FormalinLDX · Traditional | 07/28/1988SE |
| K882873 | Fieldtex HematoxylinKQC · Traditional | 07/28/1988SE |
| K882268 | Zinc Formalin ConcentrateIGG · Traditional | 06/15/1988SE |
| K881282 | XyleneKEM · Traditional | 04/05/1988SE |
| K872663 | Dry-FormIFP · Traditional | 08/06/1987SE |
| K872500 | Anatech Hematoxylin-Extra StrengthHYJ · Traditional | 07/09/1987SE |
| K872499 | Anatech Hematoxylin-Normal StrengthHYJ · Traditional | 07/09/1987SE |
| K872498 | Harris HematoxylinHYK · Traditional | 07/09/1987SE |
| K842940 | Cba FormalinIFP · Traditional | 08/28/1984SE |
| K842862 | CB FormalinIGE · Traditional | 08/28/1984SE |
Questions and answers
When was NBF 10% Neutral Buffered Formalin cleared by the FDA?
NBF 10% Neutral Buffered Formalin (K870852) received a 510(k) decision of Substantially Equivalent on March 31, 1987, 28 days after the submission was received.
What is the product code of K870852?
The FDA product code is IFP – Formalin, Neutral Buffered, a Class I (low risk) device regulated under 21 CFR 864.4010.