FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEATING BLOCK, WAMPOLE 37 C
K Number: K790549
·
Decision May 3, 1979
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
2
Applicant Total
68
Review Days
44
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Basic Information
- Device Name
- HEATING BLOCK, WAMPOLE 37 C
- K Number
- K790549
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Armkel, LLC
- Date Received
- March 20, 1979
- Decision Date
- May 3, 1979
- Product Code
- JRG
- 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 |
|---|---|---|---|
| JRG | Block, Heating | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JRG), ordered by most recent decision date.
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|---|---|---|---|
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| K013614 | TROJAN CRYSTAL CLEAR LIQUID | Feb 1, 2002 | Substantially Equivalent |
| K001212 | TROJAN EXTRA LARGE LATEX CONDOM | May 9, 2000 | Substantially Equivalent |
| K000748 | TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT | Apr 6, 2000 | Substantially Equivalent |
| K992232 | FIRST RESPONSE 1-STEP PREGNANCY | Dec 21, 1999 | Substantially Equivalent |
| K973352 | BRAND NAME *1-STEP PREGNANCY | Oct 27, 1997 | Substantially Equivalent |
| K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST | Oct 27, 1997 | Substantially Equivalent |