PREGNANCY TEST KIT, DAISY 2 IN HOME
FDA 510(k) clearance K790002 · decided 1979-02-01
Clearance details
- K-number
- K790002
- Device name
- PREGNANCY TEST KIT, DAISY 2 IN HOME
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-01-02
- Decision date
- 1979-02-01
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- JHJ
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PREGNACOL PREGNANCY TEST (K972606) | Immunostics Inc., | 1997-08-29 |
| IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST (K921968) | Tech-Co, Inc. | 1996-06-28 |
| SAS(TM) DIRECT MONOCLONAL HCG (K935863) | Sa Scientific, Inc. | 1994-02-24 |
| ACCUTEX BETA-HCG TEST (K926112) | J.S. Medical Assoc. | 1993-07-28 |
| SAS(TM) MONOCLONAL HCG-SLIDE (K930609) | Sa Scientific, Inc. | 1993-03-29 |
| DIRECT PREGNANCY TEST (K920716) | Tech-Co, Inc. | 1992-03-24 |
| CLEARVIEW HCG (K910946) | Unipath , Ltd. | 1991-04-01 |
| PREGNOSPIA II (K881435) | Organon Teknika Corp. | 1988-05-27 |
| PREGNANCY (HCG) CARD & LIQUID TEST (K880163) | Ampcor, Inc. | 1988-05-17 |
| PREGNANCY BETA-HCG CARD & LIQUID TEST (K880478) | Ampcor, Inc. | 1988-04-28 |
| HCG-NOSTICK (K880328) | Organon Teknika Corp. | 1988-03-15 |
| V-TREND BETA-HCG DRY-SPOT TEST (K875262) | Texas Immunology, Inc. | 1988-02-02 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ENZYMUN TEST{R} CEA (P860058/S001) | Boehringer Mannheim Corp. | 1993-07-29 |
| ENZYMUN-TEST{R} AFP (P860044/S003) | Boehringer Mannheim Corp. | 1991-09-03 |
| ENZYMUN-TEST{R} AFP (P860044/S002) | Boehringer Mannheim Corp. | 1991-07-19 |
| ENZYMUN-TEST{R} AFP (P860044/S001) | Boehringer Mannheim Corp. | 1990-08-03 |
| MICUR-MIC SYSTEMS (P820073) | Boehringer Mannheim Corp. | 1983-06-29 |