FDA Product Code
FDA Product Code IAF — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.1850
510(k) Clearances — 33 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K890674 | ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET | Sigma Diagnostics, Inc. | 1989-02-24 | Traditional | PDF ↗ |
| K890673 | WRIGHT-GLEMSA STAIN | Sigma Diagnostics, Inc. | 1989-02-24 | Traditional | PDF ↗ |
| K854236 | HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS | Nms Pharmaceuticals, Inc. | 1986-10-10 | Traditional | PDF ↗ |
| K860793 | CAMCO STAIN PAK | Cambridge Chemical Products, Inc. | 1986-03-18 | Traditional | PDF ↗ |
| K853241 | HEMATOLOGY STAIN PACK | Fisher Scientific Co., LLC | 1985-08-19 | Traditional | PDF ↗ |
| K852138 | WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S | Canyon Diagnostics, Inc. | 1985-06-13 | Traditional | PDF ↗ |
| K842744 | WRIGHT STAIN | E K Ind., Inc. | 1984-08-12 | Traditional | PDF ↗ |
| K842745 | WRIGHT-GIEMSA QUICK STAIN | E K Ind., Inc. | 1984-08-10 | Traditional | PDF ↗ |
| K833678 | HEMATOLOGY WRIGHT'S STAIN PACK | J.S. Medical Assoc. | 1983-11-25 | Traditional | PDF ↗ |
| K833260 | STAIN PACK FOR AEROSPRAY SLIDE STAINER | Wescor, Inc. | 1983-10-28 | Traditional | PDF ↗ |
| K831605 | HEMATOLOGY PAK | Mercedes Scientific Co., Inc. | 1983-06-30 | Traditional | PDF ↗ |
| K830542 | HEMAQUIK II STAINING SOLUTION #55961 | Accra Laboratories, Inc. | 1983-03-17 | Traditional | PDF ↗ |
| K830127 | QUIK-DIP BLOOD STAIN | Mercedes Scientific Co., Inc. | 1983-02-15 | Traditional | PDF ↗ |
| K822981 | MIDAS 1000 WRIGHT GIEMSA STAIN #66020 | Emd Chemicals, Inc. | 1982-10-27 | Traditional | PDF ↗ |
| K822980 | MIDAS 1000 WRIGHT STAIN #66010 | Emd Chemicals, Inc. | 1982-10-27 | Traditional | PDF ↗ |
| K821457 | HEMACOUNT WRIGHTS STAIN PACK II #55952 | Accra Laboratories, Inc. | 1982-06-01 | Traditional | PDF ↗ |
| K820437 | AVES WRIGHT STAIN | Helena Laboratories | 1982-03-26 | Traditional | PDF ↗ |
| K812848 | ACCRA LAB HEMOTOLOGY | Accra Laboratories, Inc. | 1981-10-23 | Traditional | PDF ↗ |
| K812504 | ACCRA LAB WRIGHT STAIN | Accra Laboratories, Inc. | 1981-09-23 | Traditional | PDF ↗ |
| K811400 | HEMAQUIK | Accra Laboratories, Inc. | 1981-06-18 | Traditional | PDF ↗ |
| K810495 | STAT STAIN SET | Accra Laboratories, Inc. | 1981-03-17 | Traditional | PDF ↗ |
| K801212 | WRIGHTS RAPID STAIN | Mcb Manufacturing Chemists, Inc. | 1980-05-30 | Traditional | PDF ↗ |
| K792497 | VOLU-SOL STATIM STAIN | Volu Sol Medical Industries | 1979-12-18 | Traditional | PDF ↗ |
| K792026 | WRIGHTS RAPID STAIN | Mcb Manufacturing Chemists, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K792017 | VOLU-SOL STAT STAIN | Volu Sol Medical Industries | 1979-10-30 | Traditional | PDF ↗ |
| K791929 | WRIGHTS RAPID STAIN | Mcb Manufacturing Chemists, Inc. | 1979-10-11 | Traditional | PDF ↗ |
| K790571 | QUIK-STAIN | Dade, Baxter Travenol Diagnostics, Inc. | 1979-04-23 | Traditional | PDF ↗ |
| K781587 | HEMATOLOGY STAIN PACK | Bioscientific | 1978-10-10 | Traditional | PDF ↗ |
| K781384 | WRIGHT RAPID STAIN | Mfg Chemists, Inc. | 1978-08-21 | Traditional | PDF ↗ |
| K781347 | CAMCO QUIK STAIN II | Cambridge Chemical Products, Inc. | 1978-08-21 | Traditional | PDF ↗ |
| K770074 | BIO-DYES FORTIFIED HEMATOLOGY STAIN | Jack W. Kindberg | 1977-03-22 | Traditional | PDF ↗ |
| K770075 | BIO-DYES HEMATOLOGY PHOSPHATE | Jack W. Kindberg | 1977-03-22 | Traditional | PDF ↗ |
| K760027 | DSP - STAIN PACK | Harleco | 1976-07-20 | Traditional | PDF ↗ |
Product code IAF · Class I · Hematology. Data: openFDA.