510(k) K810758
- Device
- GILL'S HEMATOXYLIN #1
- Applicant
- SURGIPATH
- 510(k) number
- K810758
- Product code
- HYJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-04-14
- Date received
- 1981-03-20
- Regulation
- 864.1850
- Classification name
- Hematoxylin
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3007496191
- 1937990
- 3008773547
- 9610140
- 3016764932
- 1625587
- 3009963993
- 2518071
- 3002805583
- 3013059683
- 1000138378
- 3006365273
- 1045125
- 3004140393
- 3004074729
- 1419341
- 1640981
- 3003423869
- 2247035
- 3030446844
- 3008776165
- 2013736
- 3009189893
- 2022180
- 2025606
- 1125908
- 9610099
- 3017970519
- 1831638
- 3009432145
- 3017170972
- 3030733800
- 3016741564
- 1831338
- 3014611360
- 2028492
- 2916205
- 3008174888
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HYJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K872499 | ANATECH HEMATOXYLIN-NORMAL STRENGTH | Anatech, Ltd. | 1987-07-09 |
| K872500 | ANATECH HEMATOXYLIN-EXTRA STRENGTH | Anatech, Ltd. | 1987-07-09 |
| K842740 | DELAFIELD HEMATOXYLIN STAIN | E K Ind., Inc. | 1984-08-17 |
| K842741 | GILL HEMATOXYLIN STAIN | E K Ind., Inc. | 1984-08-15 |
| K831090 | HEMATOXYLIN GILL FORMULATION IX#56016 | Accra Laboratories, Inc. | 1983-06-08 |
| K822352 | HEMATOXYLIN STAIN SOLUTION | Fisher Scientific Co., LLC | 1982-08-16 |
| K821533 | HEMATOXYLIN I | Volu Sol Medical Industries | 1982-06-10 |
| K821540 | HEMATOXYLIN II | Volu Sol Medical Industries | 1982-06-10 |
| K821541 | HEMATOXYLIN III | Volu Sol Medical Industries | 1982-06-10 |
| K821320 | HEMATOXYLIN STAIN | Sigma Chemical Co. | 1982-06-02 |
| K821062 | HEMATOXYLIN SOLUTION | Sigma Chemical Co. | 1982-04-29 |
| K811802 | HEMATOXYLIN | Richard-Allan Medical Ind., Inc. | 1981-07-28 |
| K810759 | GILL'S HEMATOXYLIN #2 | Surgipath | 1981-04-14 |
Legacy Summary#
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FDA Review#
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