Hemaquik II Staining Solution #55961
FDA 510(k) K830542 · Accra Laboratories, Inc.
510(k) numberK830542
Submission
- Device name
- Hemaquik II Staining Solution #55961
- Applicant
- Accra Laboratories, Inc.
Mchenry, IL, US - Received
- February 22, 1983
- Decision date
- March 17, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IAF – Wright'S Stain
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code IAF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K890674 | Accustain(Tm) - Automated Wright Giemsa Stain SetIAF · Traditional | Sigma Diagnostics, Inc. | 02/24/1989SE |
| K890673 | Wright-Glemsa StainIAF · Traditional | Sigma Diagnostics, Inc. | 02/24/1989SE |
| K854236 | Histamine Ria Test for Histamine Biological FluidsIAF · Traditional | Nms Pharmaceuticals, Inc. | 10/10/1986SN |
| K860793 | Camco Stain PakIAF · Traditional | Cambridge Chemical Products, Inc. | 03/18/1986SE |
| K853241 | Hematology Stain PackIAF · Traditional | Fisher Scientific Co., LLC | 08/19/1985SE |
| K852138 | Wescor Stain Pack for Model 7100 Aerospray Slide SIAF · Traditional | Canyon Diagnostics, Inc. | 06/13/1985SE |
| K842744 | Wright StainIAF · Traditional | E K Ind., Inc. | 08/12/1984SE |
| K842745 | Wright-Giemsa Quick StainIAF · Traditional | E K Ind., Inc. | 08/10/1984SE |
| K833678 | Hematology Wright's Stain PackIAF · Traditional | J.S. Medical Assoc. | 11/25/1983SE |
| K833260 | Stain Pack for Aerospray Slide StainerIAF · Traditional | Wescor, Inc. | 10/28/1983SE |
More from Wescor, 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 |
| K823329 | Papincolabu Stain EA-36/50/65 & OG-6HZL · Traditional | 12/28/1982SE |
| K823328 | Harris HematoxylinHYK · Traditional | 12/28/1982SE |
Questions and answers
When was Hemaquik II Staining Solution #55961 cleared by the FDA?
Hemaquik II Staining Solution #55961 (K830542) received a 510(k) decision of Substantially Equivalent on March 17, 1983, 23 days after the submission was received.
What is the product code of K830542?
The FDA product code is IAF – Wright'S Stain, a Class I (low risk) device regulated under 21 CFR 864.1850.