FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER
K Number: K852027
·
Decision May 29, 1985
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
28
Applicant Total
21
Review Days
21
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Basic Information
- Device Name
- GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER
- K Number
- K852027
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3830
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Advanced Biomedical Methods, Inc.
- Date Received
- May 8, 1985
- Decision Date
- May 29, 1985
- Product Code
- DKJ
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| DKJ | Colorimetry, Salicylate | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DKJ), ordered by most recent decision date.
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EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
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FDA Class 2
·Clinical Toxicology
SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Advanced Biomedical Methods, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K945353 | CLARIT(TM) | Dec 9, 1994 | Substantially Equivalent |
| K880949 | SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER | Apr 5, 1988 | Substantially Equivalent |
| K864866 | RESUBMISSION OF THE KLEERZIT REAGENT | Mar 16, 1987 | Substantially Equivalent |
| K852784 | ALKALINE PHOSPHATASE | Jul 22, 1985 | Substantially Equivalent |
| K852783 | SGOT/ALT REAGENT | Jul 22, 1985 | Substantially Equivalent |
| K850380 | INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER | Mar 1, 1985 | Substantially Equivalent |
| K850379 | DIRECT BILIRUBIN FOR DEMAND ANALYZER | Mar 1, 1985 | Substantially Equivalent |
| K850378 | LDH REAGENT FOR DEMAND ANALYZER | Mar 1, 1985 | Substantially Equivalent |
| K850381 | MAGNESIUM REAGENT FOR DEMAND ANALYZER | Mar 1, 1985 | Substantially Equivalent |
| K844331 | TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER | Jan 3, 1985 | Substantially Equivalent |