FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019
K Number: K874705
·
Decision Dec 22, 1987
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
288
Review Days
33
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Basic Information
- Device Name
- EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019
- K Number
- K874705
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Em Diagnostic Systems, Inc.
- Date Received
- November 19, 1987
- Decision Date
- December 22, 1987
- Product Code
- JEJ
- Advisory Committee
- Ear, Nose, Throat
- 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 |
|---|---|---|---|
| JEJ | Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JEJ), ordered by most recent decision date.
View allOther Clearances by Em Diagnostic Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K935180 | ALANINE AMINOTRANSFERASE (ALT) TEST | Jan 13, 1994 | Substantially Equivalent |
| K935178 | EMDS PHOSPHOROUS (PHOS) TEST | Dec 17, 1993 | Substantially Equivalent |
| K935179 | EMDS ALBUMIN (ALB) TEST | Dec 17, 1993 | Substantially Equivalent |
| K935174 | TOTAL PROTEIN TEST (TPRO) | Dec 16, 1993 | Substantially Equivalent |
| K935177 | GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST | Dec 16, 1993 | Substantially Equivalent |
| K935136 | CHOLESTEROL (CHOL) TEST ITEM NO. 65410 | Dec 16, 1993 | Substantially Equivalent |
| K935175 | LACTATE DEHYDROGENASE (LD) | Dec 16, 1993 | Substantially Equivalent |
| K935176 | IRON TEST | Dec 16, 1993 | Substantially Equivalent |
| K935183 | EMDS MAGNESIUM (MG) TEST | Dec 9, 1993 | Substantially Equivalent |