Panels › Immunology › Product code LLL · Class 2
Extractable Antinuclear Antibody, Antigen And Control
Regulation 866.5100
2510(k)s in 12 months (182 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in LLL
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 9, 1990 | K902938 | IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3 General Biometrics, Inc. | LLL |
| May 9, 1990 | K901924 | READS(R) ANTI-ENA (SM/RNP) TEST KIT Biosearch Medical Products, Inc. | LLL |
| Mar 23, 1990 | K901230 | REAADS ANTI-SM TEST KIT Biosearch Medical Products, Inc. | LLL |
| Mar 19, 1990 | K901073 | ANTI-RNP MICROASSAY Diamedix Corp. | LLL |
| Feb 23, 1990 | K900617 | SERATEST ENA [SSA] KIT Hemagen Diagnostics, Inc. | LLL |
| Feb 2, 1990 | K900241 | ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY Diamedix Corp. | LLL |
| Nov 20, 1989 | K896462 | NOVA GEL(TM) T JO-1 Inova Diagnostics, Inc. | LLL |
| Nov 20, 1989 | K896461 | NOVA GEL(TM) T SCL-70 Inova Diagnostics, Inc. | LLL |
| Nov 20, 1989 | K896460 | NOVA GEL(TM) T SS-A/SS-B Inova Diagnostics, Inc. | LLL |
| Nov 20, 1989 | K896459 | NOVA GEL(TM) T SM/RNP Inova Diagnostics, Inc. | LLL |
| Oct 4, 1989 | K895339 | ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST Immco Diagnostics, Inc. | LLL |
| May 17, 1989 | K892897 | NOVA GEL(TM) JO-1 Inova Diagnostics, Inc. | LLL |
| Sep 22, 1988 | K881341 | NOVA LITE(TM) SA Inova Diagnostics, Inc. | LLL |
| Sep 7, 1988 | K883232 | HISTONE REACTIVE ANA Val Tech Diagnostics, Inc. | LLL |
| Jun 8, 1988 | K881340 | NOVA LITE(TM) AUTOANTIBODY CONTROLS Inova Diagnostics, Inc. | LLL |
| Apr 21, 1988 | K881339 | NOVA LITE(TM) ANA PLUS Inova Diagnostics, Inc. | LLL |
| Apr 21, 1988 | K880897 | NOVA GEL (TM) SCL-70 Inova Diagnostics, Inc. | LLL |
| Apr 6, 1988 | K881181 | NOVA GEL(TM) SM/RNP Inova Diagnostics, Inc. | LLL |
| Mar 25, 1988 | K880896 | NOVA GEL(TM) SS-A/SS-B Inova Diagnostics, Inc. | LLL |
| Mar 25, 1988 | K880736 | NOVA LITE(TM) ANA Inova Diagnostics, Inc. | LLL |
| Nov 25, 1987 | K873708 | FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES Whittaker Bioproducts, Inc. | LLL |
| Aug 12, 1987 | K871994 | ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS) Behring Diagnostics, Inc. | LLL |
| Aug 19, 1986 | K862700 | SERATEST ENA [SS-B] KIT Hemagen Diagnostics, Inc. | LLL |
| Jul 29, 1986 | K862710 | KALLESTAD SSA/SSB ENA TEST REAGENTS Kallestad Laboratories, Inc. | LLL |
| May 15, 1986 | K860428 | SM-RNP AUTOANTIBODY TEST SYSTEM Immuno Concepts, Inc. | LLL |
| Mar 28, 1986 | K860644 | SS-A/SS-B AUTOANTIBODY TEST SYSTEM Immuno Concepts, Inc. | LLL |
| Feb 26, 1985 | K843423 | PHYSIO GAS ANALYZER Research Medical, Inc. | LLL |
| Feb 4, 1985 | K844743 | SERATEST ENA(RNP/SM) DETERMINATION Seragen Diagnostics, Inc. | LLL |
| Dec 18, 1984 | K843978 | ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY Behring Diagnostics, Inc. | LLL |
| May 22, 1984 | K840221 | EXTRACTABLE NUCLEAR ANTIGEN ASSAY Zeus Scientific, Inc. | LLL |
| Apr 27, 1983 | K831036 | ENA TEST KIT SM & RNP AUTO ANTIBODY Calbiochem-Behring Corp. | LLL |
| Oct 23, 1981 | K810592 | NUCLEAR ANTIGENS Alpha Antigens, Inc. | LLL |
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