FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INORGANIC PHOSPHORUS TEST
K Number: K843177
·
Decision Sep 14, 1984
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
104
Applicant Total
82
Review Days
32
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INORGANIC PHOSPHORUS TEST
- K Number
- K843177
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1580
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sclavo, Inc.
- Date Received
- August 13, 1984
- Decision Date
- September 14, 1984
- Product Code
- CEO
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEO), ordered by most recent decision date.
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ATAC PAK PHOSPHORUS REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PICCOLO PHOSPHORUS TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Sclavo, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K914789 | ELISA CMV IGM | Mar 4, 1992 | Substantially Equivalent |
| K914852 | ELISA TOXO IGM | Jan 23, 1992 | Substantially Equivalent |
| K914420 | ELISA RUBELLA IGM | Dec 27, 1991 | Substantially Equivalent |
| K895943 | NORMAL AND ABNORMAL CONTROL SERA | Dec 27, 1989 | Substantially Equivalent |
| K895822 | TOTAL BILIRUBIN L.F. | Nov 14, 1989 | Substantially Equivalent |
| K895847 | CREATININE 340 (ENZYMATIC) | Oct 30, 1989 | Substantially Equivalent |
| K880049 | CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE | Jan 27, 1989 | Substantially Equivalent |
| K880199 | CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE | Jan 27, 1989 | Substantially Equivalent |
| K873496 | ATYPICAL CHOLINESTERASE | Jan 27, 1989 | Substantially Equivalent |
| K884035 | SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER | Dec 29, 1988 | Substantially Equivalent |