Fieldtex Hematoxylin
FDA 510(k) K882873 · Anatech, Ltd.
510(k) numberK882873
Submission
- Device name
- Fieldtex Hematoxylin
- Applicant
- Anatech, Ltd.
Battle Creek, MI, US - Received
- July 11, 1988
- Decision date
- July 28, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQC – Stains, Hematology
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code KQC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K852843 | General Diagnostics Coag-A-Mate XCKQC · Traditional | Warner-Lambert Co. | 08/13/1985SE |
| K843619 | Retic-SetKQC · Traditional | R&D Systems, Inc. | 10/30/1984SE |
| K841848 | Retic-SetKQC · Traditional | R&D Systems, Inc. | 05/31/1984SE |
| K792550 | Ponceau S Stain SetKQC · Traditional | Electrophoresis Corp. of America | 01/16/1980SE |
| K792496 | Volu-Sol NMB Reticulocyte StainKQC · Traditional | Volu Sol Medical Industries | 12/31/1979SE |
| K791007 | Stat Diff StainKQC · Traditional | Bioscientific | 08/03/1979SE |
| K760487 | Hemastain Phosphate BufferKQC · Traditional | Geometric Data, Div. Smithkline Corp. | 08/30/1976SE |
| K760485 | Hemastain FixativeKQC · Traditional | Geometric Data, Div. Smithkline Corp. | 08/30/1976SE |
More from Geometric Data, Div. Smithkline Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K882874 | Zinc FormalinLDX · 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 |
| K842862 | CB FormalinIGE · Traditional | 08/28/1984SE |
Questions and answers
When was Fieldtex Hematoxylin cleared by the FDA?
Fieldtex Hematoxylin (K882873) received a 510(k) decision of Substantially Equivalent on July 28, 1988, 17 days after the submission was received.
What is the product code of K882873?
The FDA product code is KQC – Stains, Hematology, a Class I (low risk) device regulated under 21 CFR 864.1850.