Xylene
FDA 510(k) K881282 · Anatech, Ltd.
510(k) numberK881282
Submission
- Device name
- Xylene
- Applicant
- Anatech, Ltd.
Battle Creek, MI, US - Received
- March 25, 1988
- Decision date
- April 5, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KEM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K874461 | Hemo-SolKEM · Traditional | Chem Pharm, Inc. | 12/04/1987SE |
| K861490 | Permaclear Solution Cat. No. 4950KEM · Traditional | Helena Laboratories | 05/06/1986SE |
| K855109 | Clearene, Clearing AgentKEM · Traditional | Surgipath Medical Industries, Inc. | 01/07/1986SE |
| K854083 | Xylene Substitute MontantKEM · Traditional | Lerner Laboratories, Inc. | 10/22/1985SE |
| K853694 | Xylene SubstituteKEM · Traditional | Lerner Laboratories, Inc. | 10/22/1985SE |
| K842861 | Pro-Par ClearantKEM · Traditional | Anatech, Ltd. | 08/21/1984SE |
| K842721 | LimoneneKEM · Traditional | E K Ind., Inc. | 08/03/1984SE |
| K832451 | Clear-Rite 3KEM · Traditional | Richard-Allan Medical Ind., Inc. | 08/12/1983SE |
| K832011 | Ameri ClearKEM · Traditional | Stephens Scientific | 08/12/1983SE |
| K830627 | Clarifier-Richard-AllanKEM · Traditional | Richard-Allan Medical Ind., Inc. | 03/24/1983SE |
More from Richard-Allan Medical Ind., 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 |
| 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 |
| K842862 | CB FormalinIGE · Traditional | 08/28/1984SE |
Questions and answers
When was Xylene cleared by the FDA?
Xylene (K881282) received a 510(k) decision of Substantially Equivalent on April 5, 1988, 11 days after the submission was received.
What is the product code of K881282?
The FDA product code is KEM – Agent, Clearing, a Class I (low risk) device regulated under 21 CFR 864.4010.