SODIUM HYPOCHLORITE 7%
FDA 510(k) clearance K831619 · decided 1983-07-28
Clearance details
- K-number
- K831619
- Device name
- SODIUM HYPOCHLORITE 7%
- Applicant
- Omega Medical Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1983-05-19
- Decision date
- 1983-07-28
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- PPM
- Device class
- 1
- Regulation number
- 864.4010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- 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 |
|---|---|---|
| TOMTEC GRAM STAINER DECOLORIZER (K871533) | Remel Co. | 1987-04-29 |
| POTASSIUM HYDROXIDE 10% W/V (K863550) | Reagent Laboratory, Inc. | 1986-10-02 |
| 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2 (K861890) | Richard-Allan Medical Ind., Inc. | 1986-06-03 |
| SPRAYFIX (K850916) | Surgipath Medical Industries, Inc. | 1985-03-25 |
| TRANSPORT CULTURE MEDIUM (K850737) | Roseville Medical Laboratoriesu | 1985-03-20 |
| 0.85% SALINE (K850845) | Micro Media Laboratories | 1985-03-20 |
| DECOLORIZING FLUIC, ACID-ALCOHOL 3% (K842934) | E K Ind., Inc. | 1984-09-12 |
| PRO-SOFT DEHYDRANT (K842863) | Anatech, Ltd. | 1984-08-21 |
| DECOLORIZING FLUID (K842729) | E K Ind., Inc. | 1984-08-03 |
| IDD DETERGENT (K842070) | Interscience Diagnostics, Inc. | 1984-07-02 |
| SODIUM HYPOCHLORITE 3% (K831620) | Omega Medical Diagnostics | 1983-07-28 |
| BLENDED DETERGENT-78N 1912-1 (K822326) | Interscience, Inc. | 1982-10-18 |
Recalls involving this device
No recalls on record reference this clearance.