PAP STAIN EA-65
FDA 510(k) clearance K842735 · decided 1984-09-11
Clearance details
- K-number
- K842735
- Device name
- PAP STAIN EA-65
- Applicant
- E K Ind., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-13
- Decision date
- 1984-09-11
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- HZJ
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch E K Ind.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 (K843427) | Accra Laboratories, Inc. | 1984-10-02 |
| PAP STAIN, EA-36 (K842739) | E K Ind., Inc. | 1984-09-11 |
| PAP STAIN EA-50 (K842738) | E K Ind., Inc. | 1984-08-17 |
| PAP STAIN, OG-6 (K842736) | E K Ind., Inc. | 1984-08-17 |
| PAPANICOLAOU STAIN SYS HT40 (K840054) | Sigma Chemical Co. | 1984-02-17 |
| VOLU-SOL GILLS EA (K822035) | Volu Sol Medical Industries | 1982-08-03 |
| MODIFIED EA 50 (K820027) | Surgipath | 1982-02-04 |
| EA 65 (K812086) | Surgipath | 1981-08-13 |
| EA 50 (K812087) | Surgipath | 1981-08-13 |
| VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65 (K800325) | Volu Sol Medical Industries | 1980-02-26 |
| VOLU-SOL EA-50 STAIN (K800322) | Volu Sol Medical Industries | 1980-02-26 |
| PAPANICOLAOU STAIN EA-36 (K781582) | Bioscientific | 1978-10-10 |
Recalls involving this device
No recalls on record reference this clearance.