FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLUCOSE TEST ITEM NUMBER 97375/94
K Number: K951750
·
Decision Sep 6, 1995
Classifications
1
FEI Numbers
67
Registration Numbers
68
Same Product Code
72
Applicant Total
62
Review Days
142
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Basic Information
- Device Name
- GLUCOSE TEST ITEM NUMBER 97375/94
- K Number
- K951750
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Emd Chemicals, Inc.
- Date Received
- April 17, 1995
- Decision Date
- September 6, 1995
- Product Code
- LFR
- 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 |
|---|---|---|---|
| LFR | Glucose Dehydrogenase, Glucose | FDA class 2 | Clinical Chemistry |
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Other Clearances by Emd Chemicals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K031367 | DUOPATH VEROTOXINS GLISA TEST | Jan 23, 2004 | Substantially Equivalent |
| K990516 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | Mar 31, 1999 | Substantially Equivalent |
| K981926 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | Jul 22, 1998 | Substantially Equivalent |
| K973054 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | Oct 1, 1997 | Substantially Equivalent |
| K951494 | AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) | Dec 11, 1995 | Substantially Equivalent |
| K950234 | TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 | Jun 14, 1995 | Substantially Equivalent |
| K950128 | TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 | May 15, 1995 | Substantially Equivalent |
| K945322 | PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 | Dec 7, 1994 | Substantially Equivalent |
| K945368 | PHOSPHORUS TEST (PHOS) | Dec 2, 1994 | Substantially Equivalent |
| K840883 | UNIPAK 100 ANALYZER, 65156 & CHEMISTR | May 16, 1984 | Substantially Equivalent |