Pap Stain EA-65
FDA 510(k) K842735 · E K Ind., Inc.
510(k) numberK842735
Submission
- Device name
- Pap Stain EA-65
- Applicant
- E K Ind., Inc.
Mchenry, IL, US - Received
- July 13, 1984
- Decision date
- September 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HZJ – Stain, Papanicolau
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code HZJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K843427 | Gill Papanicolaou Stain EA-1 & 2 OG-6HZJ · Traditional | Accra Laboratories, Inc. | 10/02/1984SE |
| K842739 | Pap Stain, EA-36HZJ · Traditional | E K Ind., Inc. | 09/11/1984SE |
| K842738 | Pap Stain EA-50HZJ · Traditional | E K Ind., Inc. | 08/17/1984SE |
| K842736 | Pap Stain, OG-6HZJ · Traditional | E K Ind., Inc. | 08/17/1984SE |
| K840054 | Papanicolaou Stain Sys HT40HZJ · Traditional | Sigma Chemical Co. | 02/17/1984SE |
| K822035 | Volu-Sol Gills EaHZJ · Traditional | Volu Sol Medical Industries | 08/03/1982SE |
| K820027 | Modified Ea 50HZJ · Traditional | Surgipath | 02/04/1982SE |
| K812087 | Ea 50HZJ · Traditional | Surgipath | 08/13/1981SE |
| K812086 | Ea 65HZJ · Traditional | Surgipath | 08/13/1981SE |
| K800325 | Volu-Sol Histo./Cyto. Stain Mod. #EA65HZJ · Traditional | Volu Sol Medical Industries | 02/26/1980SE |
More from Volu Sol Medical Industries
| 510(k) | Device | Decision |
|---|---|---|
| K842931 | Drabkin ReagentKAG · Traditional | 09/21/1984SE |
| K842938 | Acetic Acid 1% V/VGGK · Traditional | 09/14/1984SE |
| K842937 | Acetic Acid 2% V/VGGK · Traditional | 09/12/1984SE |
| K842936 | Acetic Acid, 3% V/VGGK · Traditional | 09/12/1984SE |
| K842935 | Acetic Acid, 5% V/VGGK · Traditional | 09/12/1984SE |
| K842934 | Decolorizing Fluic, Acid-Alcohol 3%PPM · Traditional | 09/12/1984SE |
| K842933 | Carbol-Fuchsin, Ziehl-NeedsenICL · Traditional | 09/11/1984SE |
| K842930 | Gomori's Trichrome StainLED · Traditional | 09/11/1984SE |
| K842928 | Jenner Blood StainKJX · Traditional | 09/11/1984SE |
| K842927 | Light Green SF 1%HYS · Traditional | 09/11/1984SE |
Questions and answers
When was Pap Stain EA-65 cleared by the FDA?
Pap Stain EA-65 (K842735) received a 510(k) decision of Substantially Equivalent on September 11, 1984, 60 days after the submission was received.
What is the product code of K842735?
The FDA product code is HZJ – Stain, Papanicolau, a Class I (low risk) device regulated under 21 CFR 864.1850.