FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHEMSTRIP G
K Number: K770271
·
Decision Mar 16, 1977
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
80
Applicant Total
340
Review Days
30
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Basic Information
- Device Name
- CHEMSTRIP G
- K Number
- K770271
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1340
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Boehringer Mannheim Corp.
- Date Received
- February 14, 1977
- Decision Date
- March 16, 1977
- Product Code
- JIL
- 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 |
|---|---|---|---|
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K984105 | ELECSYS TROPONIN T STAT TEST | Dec 8, 1998 | Substantially Equivalent |
| K983503 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 | Dec 1, 1998 | Substantially Equivalent |
| K983469 | PRECISET SERUM PROTEINS CALIBRATOR | Nov 25, 1998 | Substantially Equivalent |
| K983185 | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | Nov 12, 1998 | Substantially Equivalent |
| K982949 | ELECSYS PSA, MODEL 2010 | Oct 27, 1998 | Substantially Equivalent |