510(k) K861211
- Device
- MONO ACU-SLIDE TEST
- Applicant
- CAL-TECH DIAGNOSTICS, INC.
- 510(k) number
- K861211
- Product code
- JHJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-11-05
- Date received
- 1986-03-31
- Regulation
- 862.1155
- Classification name
- Agglutination Method, Human Chorionic Gonadotropin
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHEN, PH.D.
- Address
- 1110 Monterey Pass Rd. Monterey Park CA US 91754 91754
FDA Registration Numbers#
- 1220477
- 8043909
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JHJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972606 | PREGNACOL PREGNANCY TEST | Immunostics Inc., | 1997-08-29 |
| K921968 | IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST | Tech-Co, Inc. | 1996-06-28 |
| K935863 | SAS(TM) DIRECT MONOCLONAL HCG | Sa Scientific, Inc. | 1994-02-24 |
| K926112 | ACCUTEX BETA-HCG TEST | J.S. Medical Assoc. | 1993-07-28 |
| K930609 | SAS(TM) MONOCLONAL HCG-SLIDE | Sa Scientific, Inc. | 1993-03-29 |
| K920716 | DIRECT PREGNANCY TEST | Tech-Co, Inc. | 1992-03-24 |
| K910946 | CLEARVIEW HCG | Unipath , Ltd. | 1991-04-01 |
| K881435 | PREGNOSPIA II | Organon Teknika Corp. | 1988-05-27 |
| K880163 | PREGNANCY (HCG) CARD & LIQUID TEST | Ampcor, Inc. | 1988-05-17 |
| K880478 | PREGNANCY BETA-HCG CARD & LIQUID TEST | Ampcor, Inc. | 1988-04-28 |
| K880328 | HCG-NOSTICK | Organon Teknika Corp. | 1988-03-15 |
| K875262 | V-TREND BETA-HCG DRY-SPOT TEST | Texas Immunology, Inc. | 1988-02-02 |
| K874638 | V-TREND BETA-HCG TEST | Texas Immunology, Inc. | 1988-01-21 |
| K871294 | ACU-PREG-AL SLIDE TEST | Papibris Scientific, Inc. | 1987-05-12 |
| K863741 | IMMUNO-CEPT D (BETA-MONOCLONAL) | Immunostics Co., Inc. | 1986-11-13 |
Legacy Summary#
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FDA Review#
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