IAF
33 FDA 510(k) clearances · Product code
22 daysmedian time to decision
43 days90th percentile
33clearances measured
FDA profile
- Official device name
- Wright'S Stain
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Medical specialty
- Hematology
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| WRIGHT-GLEMSA STAIN (K890673) | Sigma Diagnostics, Inc. | 1989-02-24 |
| ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET (K890674) | Sigma Diagnostics, Inc. | 1989-02-24 |
| HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS (K854236) | Nms Pharmaceuticals, Inc. | 1986-10-10 |
| CAMCO STAIN PAK (K860793) | Cambridge Chemical Products, Inc. | 1986-03-18 |
| HEMATOLOGY STAIN PACK (K853241) | Fisher Scientific Co., LLC | 1985-08-19 |
| WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S (K852138) | Canyon Diagnostics, Inc. | 1985-06-13 |
| WRIGHT STAIN (K842744) | E K Ind., Inc. | 1984-08-12 |
| WRIGHT-GIEMSA QUICK STAIN (K842745) | E K Ind., Inc. | 1984-08-10 |
| HEMATOLOGY WRIGHT'S STAIN PACK (K833678) | J.S. Medical Assoc. | 1983-11-25 |
| STAIN PACK FOR AEROSPRAY SLIDE STAINER (K833260) | Wescor, Inc. | 1983-10-28 |
| HEMATOLOGY PAK (K831605) | Mercedes Scientific Co., Inc. | 1983-06-30 |
| HEMAQUIK II STAINING SOLUTION #55961 (K830542) | Accra Laboratories, Inc. | 1983-03-17 |
| QUIK-DIP BLOOD STAIN (K830127) | Mercedes Scientific Co., Inc. | 1983-02-15 |
| MIDAS 1000 WRIGHT GIEMSA STAIN #66020 (K822981) | Emd Chemicals, Inc. | 1982-10-27 |
| MIDAS 1000 WRIGHT STAIN #66010 (K822980) | Emd Chemicals, Inc. | 1982-10-27 |
| HEMACOUNT WRIGHTS STAIN PACK II #55952 (K821457) | Accra Laboratories, Inc. | 1982-06-01 |
| AVES WRIGHT STAIN (K820437) | Helena Laboratories | 1982-03-26 |
| ACCRA LAB HEMOTOLOGY (K812848) | Accra Laboratories, Inc. | 1981-10-23 |
| ACCRA LAB WRIGHT STAIN (K812504) | Accra Laboratories, Inc. | 1981-09-23 |
| HEMAQUIK (K811400) | Accra Laboratories, Inc. | 1981-06-18 |
| STAT STAIN SET (K810495) | Accra Laboratories, Inc. | 1981-03-17 |
| WRIGHTS RAPID STAIN (K801212) | Mcb Manufacturing Chemists, Inc. | 1980-05-30 |
| VOLU-SOL STATIM STAIN (K792497) | Volu Sol Medical Industries | 1979-12-18 |
| WRIGHTS RAPID STAIN (K792026) | Mcb Manufacturing Chemists, Inc. | 1979-11-13 |
| VOLU-SOL STAT STAIN (K792017) | Volu Sol Medical Industries | 1979-10-30 |
| WRIGHTS RAPID STAIN (K791929) | Mcb Manufacturing Chemists, Inc. | 1979-10-11 |
| QUIK-STAIN (K790571) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-04-23 |
| HEMATOLOGY STAIN PACK (K781587) | Bioscientific | 1978-10-10 |
| CAMCO QUIK STAIN II (K781347) | Cambridge Chemical Products, Inc. | 1978-08-21 |
| WRIGHT RAPID STAIN (K781384) | Mfg Chemists, Inc. | 1978-08-21 |
| BIO-DYES FORTIFIED HEMATOLOGY STAIN (K770074) | Jack W. Kindberg | 1977-03-22 |
| BIO-DYES HEMATOLOGY PHOSPHATE (K770075) | Jack W. Kindberg | 1977-03-22 |
| DSP - STAIN PACK (K760027) | Harleco | 1976-07-20 |
Track IAF automatically
Every clearance here is in the API, with alerts when new ones post.