SCOTTS TAP WATER SUBSTITUTE 7
FDA 510(k) clearance K841423 · decided 1984-05-22
Clearance details
- K-number
- K841423
- Device name
- SCOTTS TAP WATER SUBSTITUTE 7
- Applicant
- Reagent Laboratory, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-04-05
- Decision date
- 1984-05-22
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- JCC
- 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 |
|---|---|---|
| SCOTTS TAP WATER SUBSTITUTE (K842918) | E K Ind., Inc. | 1984-09-11 |
| WRIGHT STAIN BUFFER (K842914) | E K Ind., Inc. | 1984-09-07 |
| PHOSPHATE BUFFERED SALINE (1X) (K811791) | Dutchland Laboratories, Inc. | 1981-08-25 |
| CITRATE BUFFER (K811251) | Bioscientific | 1981-05-21 |
| MOPSO BUFFER (K792574) | Electrophoresis Corp. of America | 1980-01-21 |
| SMAC SYSTEM (K770508) | Mid Tech, Inc. | 1977-05-09 |
Recalls involving this device
No recalls on record reference this clearance.