NSULIN RIA KIT 125I
FDA 510(k) clearance K771628 · decided 1977-09-20
Clearance details
- K-number
- K771628
- Device name
- NSULIN RIA KIT 125I
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1977-08-26
- Decision date
- 1977-09-20
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- CFP
- Device class
- 1
- Regulation number
- 862.1405
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Washington, DC, 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 |
|---|---|---|
| ALPCO/MERCODIA INSULIN ELISA (K963911) | American Laboratory Products Co., Ltd. | 1996-11-01 |
| ACCESS ULTRASENSITIVE INSULIN ASSAY (K953084) | Bio-Rad Laboratories, Inc. | 1995-09-25 |
| IMX INSULIN (K920109) | Abbott Laboratories | 1992-05-07 |
| DSL INSULIN RIA (DSL 1600) (K914820) | Diagnostic Systems Laboratories, Inc. | 1992-01-09 |
| AIA-PACK IRI (K903628) | Tosoh Corp. | 1990-09-07 |
| ENZYMUN TEST(R) INSULIN (K901135) | Boehringer Mannheim Corp. | 1990-04-03 |
| REP(TM) SPE PLUS-30 PROCEDURES (K896572) | Helena Laboratories | 1990-01-11 |
| RIA-GNOST INSULIN (K890837) | Cambridge Medical Technology | 1989-04-26 |
| PHARMACIA INSULIN RIA (K851071) | Pharmacia, Inc. | 1985-04-12 |
| INSULIN RADIOIMMUNOASSAY KIT (K841573) | Sorin Biomedica, Fiat, USA, Inc. | 1984-05-16 |
| WAKO INSULIN TEST (K823939) | Wako Chemicals USA, Inc. | 1983-01-28 |
| COVALENT COAT RIA KIT (K822509) | Immuchem Corp. | 1982-09-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |