KNAI SODIUM POTASSIUM ANALYZER
FDA 510(k) clearance K830805 · decided 1983-04-08
Clearance details
- K-number
- K830805
- Device name
- KNAI SODIUM POTASSIUM ANALYZER
- Applicant
- Radiometer America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-14
- Decision date
- 1983-04-08
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- JSG
- Device class
- 1
- Regulation number
- 866.2300
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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 |
|---|---|---|
| THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (K882495) | Lakewood Biochemical Co., Inc. | 1988-07-01 |
| OF BASAL MEDIUM (K881550) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| TRYPTOSE AGAR (K881558) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| DEXTROSE TRYPTONE BROTH (K881523) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| BLOOD AGAR BASE W/LOW PH (K881532) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| TRYPTONE (K881557) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| HEART INFUSION AGAR (K881542) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| TRYPTOSE PHOSPHATE BROTH (K881563) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| DEXTROSE AGAR (K881522) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| MALT EXTRACT (K881545) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT (K881564) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| SKIM MILK DEHYDRATED (K881554) | Acumedia Manufacturers, Inc. | 1988-04-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S004) | Radiometer America, Inc. | 1986-02-21 |
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S003) | Radiometer America, Inc. | 1985-02-22 |
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S002) | Radiometer America, Inc. | 1984-03-01 |
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S001) | Radiometer America, Inc. | 1981-09-21 |