FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ULTRACHEM CREA #64972
K Number: K821472
·
Decision Jun 3, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
62
Review Days
16
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Basic Information
- Device Name
- ULTRACHEM CREA #64972
- K Number
- K821472
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Emd Chemicals, Inc.
- Date Received
- May 18, 1982
- Decision Date
- June 3, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- CH
- Third Party
- N
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| K951750 | GLUCOSE TEST ITEM NUMBER 97375/94 | Sep 6, 1995 | Substantially Equivalent |
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| 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 |