Histamine Ria Test for Histamine Biological Fluids
FDA 510(k) K854236 · Nms Pharmaceuticals, Inc.
510(k) numberK854236
Submission
- Device name
- Histamine Ria Test for Histamine Biological Fluids
- Applicant
- Nms Pharmaceuticals, Inc.
Newport Beach, CA, US - Received
- October 21, 1985
- Decision date
- October 10, 1986
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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 |
| 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 |
| K831605 | Hematology PakIAF · Traditional | Mercedes Scientific Co., Inc. | 06/30/1983SE |
More from Mercedes Scientific Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K861202 | Tru-Level Control Immunoassay ControlsJJY · Traditional | 01/09/1987SE |
| K860828 | Foretel, Color Ovulation TestCEP · Traditional | 08/04/1986SE |
| K853925 | Quantitative Determination of HCG in Serum-ElisaJHI · Traditional | 12/02/1985SE |
| K851445 | Color Ovulation TestCEP · Traditional | 07/29/1985SE |
| K850431 | Ez-Detect Visual Color Test for Blood in StoolKHE · Traditional | 06/17/1985SE |
| K850786 | Total Hige Enzyme ImmunoassayDGC · Traditional | 04/12/1985SE |
| K850787 | Solid Phase Free Estriol Enzyme ImmunoassayCGI · Traditional | 03/26/1985SE |
| K842499 | NMS 1043 Enzyme Immunoassay KitJHI · Traditional | 09/14/1984SE |
Questions and answers
When was Histamine Ria Test for Histamine Biological Fluids cleared by the FDA?
Histamine Ria Test for Histamine Biological Fluids (K854236) received a 510(k) decision of Substantially Equivalent for Some Indications on October 10, 1986, 354 days after the submission was received.
What is the product code of K854236?
The FDA product code is IAF – Wright'S Stain, a Class I (low risk) device regulated under 21 CFR 864.1850.