HEMOLYSE
FDA 510(k) clearance K781121 · decided 1978-08-14
Clearance details
- K-number
- K781121
- Device name
- HEMOLYSE
- Applicant
- Electrophoresis Corp. of America
- Decision
- Substantially Equivalent
- Date received
- 1978-07-03
- Decision date
- 1978-08-14
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- GGK
- Device class
- 1
- Regulation number
- 864.8540
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II (K883836) | Coulter Immunology | 1988-11-30 |
| KVM HEMOGLOBIN LYSING REAGENT (K883991) | Kvm Technologies, Inc. | 1988-10-12 |
| FISHER DIAGNOSTICS HEMATALL III LAS REAGENT (K874054) | Fisher Scientific Co., LLC | 1987-10-20 |
| CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. (K873348) | Abbott Diagnostics | 1987-09-09 |
| PIASTRINIT (K863114) | J. D. Assoc. | 1986-11-06 |
| HEMOLYSE (K863503) | Reagent Laboratory, Inc. | 1986-10-03 |
| NSI LYSING-D REAGENT -4000 ML (K850944) | Nobel Scientific Industries, Inc. | 1985-03-29 |
| LASER-LYSE (K850097) | Hematology Marketing Assoc. | 1985-03-29 |
| ACETIC ACID 1% V/V (K842938) | E K Ind., Inc. | 1984-09-14 |
| ACETIC ACID 2% V/V (K842937) | E K Ind., Inc. | 1984-09-12 |
| ACETIC ACID, 3% V/V (K842936) | E K Ind., Inc. | 1984-09-12 |
| ACETIC ACID, 5% V/V (K842935) | E K Ind., Inc. | 1984-09-12 |
Recalls involving this device
No recalls on record reference this clearance.