FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOXI-LAB RAPID SCREEN
K Number: K823523
·
Decision Jan 14, 1983
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
28
Applicant Total
38
Review Days
46
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Basic Information
- Device Name
- TOXI-LAB RAPID SCREEN
- K Number
- K823523
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3830
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Marion Laboratories, Inc.
- Date Received
- November 29, 1982
- Decision Date
- January 14, 1983
- 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.
ADVIA CHEMISTRY SALICYLATE REAGENT
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FDA Class 2
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SALICYLATE-SL ASSAY
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SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
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FDA Class 2
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SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
FDA 510(k)
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 Marion Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883391 | POLYMER ADHESIVE BANDAGE | Mar 23, 1989 | Substantially Equivalent for Some Indications |
| K875182 | MODIFIED LABELING FOR TOXI-LAB THC SCREEN | Jul 5, 1988 | Substantially Equivalent |
| K875181 | MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM | May 27, 1988 | Substantially Equivalent |
| K874554 | ENVICLUSIVE (TM) | Mar 11, 1988 | Substantially Equivalent |
| K874551 | ENVINET(TM) | Jan 22, 1988 | Substantially Equivalent for Some Indications |
| K874552 | ENVISAN PAD | Jan 22, 1988 | Substantially Equivalent for Some Indications |
| K874553 | ENVISAN PASTE | Dec 18, 1987 | Substantially Equivalent for Some Indications |
| K870864 | CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST | Apr 14, 1987 | Substantially Equivalent |
| K863485 | MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST | Sep 17, 1986 | Substantially Equivalent |
| K862123 | BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE | Jun 16, 1986 | Substantially Equivalent |