CB Formalin
FDA 510(k) K842862 · Anatech, Ltd.
510(k) numberK842862
Submission
- Device name
- CB Formalin
- Applicant
- Anatech, Ltd.
Mchenry, IL, US - Received
- July 23, 1984
- Decision date
- August 28, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IGE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950560 | Saline Solutine, SterileIGE · Traditional | Busse Hospital Disposables, Inc. | 05/30/1995SE |
More from Busse Hospital Disposables, 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 |
| K870852 | NBF 10% Neutral Buffered FormalinIFP · Traditional | 03/31/1987SE |
| K842940 | Cba FormalinIFP · Traditional | 08/28/1984SE |
Questions and answers
When was CB Formalin cleared by the FDA?
CB Formalin (K842862) received a 510(k) decision of Substantially Equivalent on August 28, 1984, 36 days after the submission was received.
What is the product code of K842862?
The FDA product code is IGE – Solution, Formalin Ammonium Bromide, a Class I (low risk) device regulated under 21 CFR 864.4010.