Papincolabu Stain EA-36/50/65 & OG-6
FDA 510(k) K823329 · Accra Laboratories, Inc.
510(k) numberK823329
Submission
- Device name
- Papincolabu Stain EA-36/50/65 & OG-6
- Applicant
- Accra Laboratories, Inc.
Mchenry, IL, US - Received
- November 8, 1982
- Decision date
- December 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HZL – Phloxine B
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
More from Accra Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K851494 | Two-Step Acid Fast Bacteria StainJTS · Traditional | 04/29/1985SE |
| K851493 | Kinyoun Acid Fast Stain KitJTS · Traditional | 04/29/1985SE |
| K843427 | Gill Papanicolaou Stain EA-1 & 2 OG-6HZJ · Traditional | 10/02/1984SE |
| K843425 | Harris Hematoxylin, Mercury Free, AcidHYK · Traditional | 10/02/1984SE |
| K843428 | BiofixLDZ · Traditional | 09/27/1984SE |
| K843426 | Eosin Y 1% AlcoholicHYB · Traditional | 09/27/1984SE |
| K843429 | Gram Stain Set W/Stabilized IodineJTS · Traditional | 09/14/1984SE |
| K831090 | Hematoxylin Gill Formulation IX#56016HYJ · Traditional | 06/08/1983SE |
| K830542 | Hemaquik II Staining Solution #55961IAF · Traditional | 03/17/1983SE |
| K823328 | Harris HematoxylinHYK · Traditional | 12/28/1982SE |
Questions and answers
When was Papincolabu Stain EA-36/50/65 & OG-6 cleared by the FDA?
Papincolabu Stain EA-36/50/65 & OG-6 (K823329) received a 510(k) decision of Substantially Equivalent on December 28, 1982, 50 days after the submission was received.
What is the product code of K823329?
The FDA product code is HZL – Phloxine B, a Class I (low risk) device regulated under 21 CFR 864.1850.