Papanicolaou Stain EA-36
FDA 510(k) K781582 · Bioscientific
510(k) numberK781582
Submission
- Device name
- Papanicolaou Stain EA-36
- Applicant
- Bioscientific
Mchenry, IL, US - Received
- September 18, 1978
- Decision date
- October 10, 1978
- 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 |
| K842735 | Pap Stain EA-65HZJ · 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 |
More from Surgipath
| 510(k) | Device | Decision |
|---|---|---|
| K812447 | Amylase Reagent KitKHM · Traditional | 09/09/1981SE |
| K811251 | Citrate BufferJCC · Traditional | 05/21/1981SE |
| K801268 | Hemoglobin Control LevelsKHG · Traditional | 07/14/1980SE |
| K801267 | Red Blood Cell Count & Hematocrit CNTLJPK · Traditional | 07/14/1980SE |
| K801265 | White Blood Cell Count Control LevelsJPK · Traditional | 07/14/1980SE |
| K791658 | Wright Stain Pack · Traditional | 10/17/1979SE |
| K791007 | Stat Diff StainKQC · Traditional | 08/03/1979SE |
| K790415 | HCP-7JPK · Traditional | 04/04/1979SE |
| K781734 | Sodium Chloride, 0.85% · Traditional | 10/24/1978SE |
| K781588 | Papanicolaou Stian OG-6HZJ · Traditional | 10/10/1978SE |
Questions and answers
When was Papanicolaou Stain EA-36 cleared by the FDA?
Papanicolaou Stain EA-36 (K781582) received a 510(k) decision of Substantially Equivalent on October 10, 1978, 22 days after the submission was received.
What is the product code of K781582?
The FDA product code is HZJ – Stain, Papanicolau, a Class I (low risk) device regulated under 21 CFR 864.1850.