Product code IAF
- Device name
- Wright'S Stain
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.1850
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890674 | ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET | Sigma Diagnostics, Inc. | 1989-02-24 |
| K890673 | WRIGHT-GLEMSA STAIN | Sigma Diagnostics, Inc. | 1989-02-24 |
| K854236 | HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS | Nms Pharmaceuticals, Inc. | 1986-10-10 |
| K860793 | CAMCO STAIN PAK | Cambridge Chemical Products, Inc. | 1986-03-18 |
| K853241 | HEMATOLOGY STAIN PACK | Fisher Scientific Co., LLC | 1985-08-19 |
| K852138 | WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S | Canyon Diagnostics, Inc. | 1985-06-13 |
| K842744 | WRIGHT STAIN | E K Ind., Inc. | 1984-08-12 |
| K842745 | WRIGHT-GIEMSA QUICK STAIN | E K Ind., Inc. | 1984-08-10 |
| K833678 | HEMATOLOGY WRIGHT'S STAIN PACK | J.S. Medical Assoc. | 1983-11-25 |
| K833260 | STAIN PACK FOR AEROSPRAY SLIDE STAINER | Wescor, Inc. | 1983-10-28 |
| K831605 | HEMATOLOGY PAK | Mercedes Scientific Co., Inc. | 1983-06-30 |
| K830542 | HEMAQUIK II STAINING SOLUTION #55961 | Accra Laboratories, Inc. | 1983-03-17 |
| K830127 | QUIK-DIP BLOOD STAIN | Mercedes Scientific Co., Inc. | 1983-02-15 |
| K822981 | MIDAS 1000 WRIGHT GIEMSA STAIN #66020 | Emd Chemicals, Inc. | 1982-10-27 |
| K822980 | MIDAS 1000 WRIGHT STAIN #66010 | Emd Chemicals, Inc. | 1982-10-27 |
| K821457 | HEMACOUNT WRIGHTS STAIN PACK II #55952 | Accra Laboratories, Inc. | 1982-06-01 |
| K820437 | AVES WRIGHT STAIN | Helena Laboratories | 1982-03-26 |
| K812848 | ACCRA LAB HEMOTOLOGY | Accra Laboratories, Inc. | 1981-10-23 |
| K812504 | ACCRA LAB WRIGHT STAIN | Accra Laboratories, Inc. | 1981-09-23 |
| K811400 | HEMAQUIK | Accra Laboratories, Inc. | 1981-06-18 |
| K810495 | STAT STAIN SET | Accra Laboratories, Inc. | 1981-03-17 |
| K801212 | WRIGHTS RAPID STAIN | Mcb Manufacturing Chemists, Inc. | 1980-05-30 |
| K792497 | VOLU-SOL STATIM STAIN | Volu Sol Medical Industries | 1979-12-18 |
| K792026 | WRIGHTS RAPID STAIN | Mcb Manufacturing Chemists, Inc. | 1979-11-13 |
| K792017 | VOLU-SOL STAT STAIN | Volu Sol Medical Industries | 1979-10-30 |
| K791929 | WRIGHTS RAPID STAIN | Mcb Manufacturing Chemists, Inc. | 1979-10-11 |
| K790571 | QUIK-STAIN | Dade, Baxter Travenol Diagnostics, Inc. | 1979-04-23 |
| K781587 | HEMATOLOGY STAIN PACK | Bioscientific | 1978-10-10 |
| K781384 | WRIGHT RAPID STAIN | Mfg Chemists, Inc. | 1978-08-21 |
| K781347 | CAMCO QUIK STAIN II | Cambridge Chemical Products, Inc. | 1978-08-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414619262 | Atellica HEMA SMS M-W Buffer | Siemens Healthcare Diagnostics Inc. | 2026-02-06 |
| 00630414626253 | Atellica HEMA SMS M-W Stain | Siemens Healthcare Diagnostics Inc. | 2026-02-06 |
| 14719874743564 | LensHooke Sperm DNA fragmentation rapid test kit (SCD assay) | BONRAYBIO CO., LTD. | 2026-02-06 |
| 00630414323633 | Atellica HEMA SMS M-W Stain | Siemens Healthcare Diagnostics Inc. | 2026-02-06 |
| 00630414323619 | Atellica HEMA SMS M-W Buffer | Siemens Healthcare Diagnostics Inc. | 2026-02-06 |
| 14719874742802 | LensHooke Sperm DNA fragmentation rapid test kit (SCD assay) | BONRAYBIO CO., LTD. | 2025-02-16 |
| 14719874742796 | LensHooke Sperm DNA fragmentation rapid test kit (SCD assay) | BONRAYBIO CO., LTD. | 2025-02-16 |
| 00673693090391 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-10-21 |
| 00673693067744 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-06 |
| 00673693090407 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-05 |
| 00673693090384 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-05 |
| 00673693068161 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-05 |
| 00860011780526 | Chemical Service Labs, LLC | Protean Resources, LLC. | 2024-03-18 |
| 00860011780502 | Chemical Service Labs, LLC | Protean Resources, LLC. | 2024-03-18 |
| 00860011780519 | Chemical Service Labs, LLC | Protean Resources, LLC. | 2024-03-18 |
| 04048474058277 | Histamine ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 00840239058270 | Histamine ELISA | DRG International Inc | 2023-08-26 |
| 07290016650617 | QwikCheck DFI Kit | M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. | 2023-06-08 |
| 14719874741591 | LensHooke Sperm DNA fragmentation test kit (SCD assay) | BONRAYBIO CO., LTD. | 2021-11-18 |
| 00630414473499 | Hematek® Stain Pak - Modified Wright's Stain | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414503936 | ADVIA® Autoslide Modified Wright's Stain | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414503967 | ADVIA® Autoslide Modified Wright's Buffer | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 10885380152283 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2018-01-30 |