FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROCHECK LH OVULATION TEST
K Number: K871602
·
Decision Jun 11, 1987
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
26
Review Days
48
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Basic Information
- Device Name
- MICROCHECK LH OVULATION TEST
- K Number
- K871602
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Syntron Bioresearch, Inc.
- Date Received
- April 24, 1987
- Decision Date
- June 11, 1987
- Product Code
- CEP
- 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 |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | FDA class 1 | Clinical Chemistry |
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Other Clearances by Syntron Bioresearch, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993490 | QUICKSTRIP ONE STEP OPIATES TEST | Oct 29, 1999 | Substantially Equivalent |
| K993491 | QUICKPAC II ONE STEP OPIATES TEST | Oct 29, 1999 | Substantially Equivalent |
| K992990 | QUICKPAC II ONE STEP COCAINE TEST | Sep 20, 1999 | Substantially Equivalent |
| K992748 | DRUGCHECK X MULTIDRUG SCREENING DEVICE | Sep 2, 1999 | Substantially Equivalent |
| K992207 | QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM | Jul 22, 1999 | Substantially Equivalent |
| K990325 | QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE | Jun 24, 1999 | Substantially Equivalent |
| K983113 | BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT | Nov 18, 1998 | Substantially Equivalent |
| K981292 | QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST | May 26, 1998 | Substantially Equivalent |
| K981019 | QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST | May 7, 1998 | Substantially Equivalent |
| K980349 | QUICKPAC II ONE STEP BARBITURATE TEST | Mar 3, 1998 | Substantially Equivalent |