FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRUST RPR TITRATION CARD TEST #65145
K Number: K832480
·
Decision Sep 12, 1983
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
31
Applicant Total
62
Review Days
48
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Basic Information
- Device Name
- TRUST RPR TITRATION CARD TEST #65145
- K Number
- K832480
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3820
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Emd Chemicals, Inc.
- Date Received
- July 26, 1983
- Decision Date
- September 12, 1983
- Product Code
- GMQ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GMQ | Antigens, Nontreponemal, All | FDA class 2 | Microbiology |
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THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST
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|---|---|---|---|
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| 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 |
| K951750 | GLUCOSE TEST ITEM NUMBER 97375/94 | Sep 6, 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 |